Colonoscopy is the gold standard for visualisation and diagnosis of conditions involving the colon and terminal ileum. However, colonoscopy is often associated with high levels of anxiety due to the anticipation of pain and possible outcome (Martindale et al, 2014). This can lead to an increased use of sedative and analgesic drugs during the colonoscopy and thus the potential for patients to be less willing to repeat the procedure (Hayes et al, 2003) with associated negative medical implications (Hayes et al, 2003; Martindale et al, 2014).
Previous studies have shown beneficial effects of interventions such as music before and during colonoscopy including on the anxiety level, stress level, vital signs, consumption of sedative and analgesic drugs, the duration of the colonoscopy and caecal intubation rates (Schiemann et al, 2002; Hayes et al, 2003; López-Cepero Andrada et al, 2004; Bechtold et al, 2009). However, results so far are contradictory and inconclusive due to factors including varying types of music, timing and type of music delivery and small sample sizes.
MusiCure is music specially designed to relieve stress and have a calming and relaxing effect (https://musicure.com/). MusiCure music has previously been tested in different medical settings with good results (Nilsson et al, 2009; Jeppesen et al, 2019); however, to the authors' knowledge, the effect of MusiCure music in relation to colonoscopy has never been investigated. To add to the body of research, a large randomised trial was designed, to investigate the effects of a specially designed music intervention delivered to the patient before and during colonoscopy, and using the MusiCure pillow device for delivery of music during colonoscopy, which allows contact with the patient during music delivery (as opposed to headphones/earphones, which present a barrier to communication).
The aims of the present study were to evaluate the effect of a music intervention with MusiCure music, both before and during colonoscopy, with regard to pain intensity, duration of the colonoscopy, consumption of alfentanil and midazolam, vital signs, patient satisfaction and caecal intubation rates.
Methods
Study population
A prospective, randomised, controlled trial was conducted at the endoscopy clinic at Horsens Regional Hospital, Denmark. The study was approved by the Danish Data Protection Agency (1-16-02-71-16) and the Central Denmark Region Committees on Health Ethics (CDRCH) (1-10-72-3-16).
Patients were referred to the endoscopy clinic from a hospital ward, outpatient clinic or the general or specialist practitioner for either an elective or sub-acute (urgent/cancer) colonoscopy. Patients were enrolled from 1 April to 1 December 2017. After obtaining written informed consent, 337 patients were enrolled. Inclusion criteria were colonoscopy-naïve adults (≥18 years). Exclusion criteria were inability to communicate in Danish, psychiatric illness or neurological illness with cognitive impairment, stoma, treatment with propofol, previous hysterectomy or deafness.
Randomisation and intervention
On the day of the colonoscopy, patients were randomised either to the intervention group (music intervention) or the control group (no music/standard care) by using sequentially numbered opaque-sealed envelopes. The randomisation was performed with varying block sizes (between 12 and 20) and was stratified by endoscopy suite to minimise the impact of the colonoscopist on the results. The randomisation sequence was generated by a statistical consultant and stored on a computer only accessible to the investigator.
Patients in the intervention group listened to specially designed MusiCure music at two time points:
- On headphones for approximately 30 minutes in the waiting room before the colonoscopy
- On a MusiCure pillow during the colonoscopy. The MusiCure pillow allowed patients to listen to music and follow the guidance of the nurse and colonoscopist at the same time during the procedure.
The music was designed by Niels Eje at MusiCure especially for this project. The composition consisted of instrumental acoustic music with integrated sounds of nature, intended to form a connection with everyone no matter their taste in music, listening habits and preferences.
Patients in the control group received standard care and treatment with no music in the waiting room or during the colonoscopy.
Care and treatment
The colonoscopies in both groups were performed by gastroenterologists, gastrointestinal surgeons or endoscopy nurses.
According to the standard protocol for pain treatment patients were treated with as-needed sedation and analgesics: bolus doses of intravenous (IV) midazolam with a maximum of 3 mg and bolus doses of alfentanil 0.25 mcg IV with a maximum of 0.03 mcg/kg. Alfentanil was chosen as the opioid analgesic because of its faster onset and shorter duration compared with fentanyl and sufentanil.
Data collection and outcome measures
Patients were assessed at four different time points: immediately after enrolment in the preparation area (T0), in the endoscopy room before the colonoscopy (T1), during the colonoscopy (T2) and after the colonoscopy in the recovery room (T3) (Table 1)
Table 1. Outcomes and data collection
| Before colonoscopy | During colonoscopy | After colonoscopy | ||
|---|---|---|---|---|
| Time point* | T0 | T1 | T2 | T3 |
| Place | Preparation area | Waiting area | Endoscopy room | Recovery room |
| Intervention (following randomisation) | Intervention group | MusiCure music on headphones | MusiCure music on a MusiCure pillow | – |
| Control group | – | – | – | |
| Data collection (Both groups) | Baseline characteristics | Level of anxietyVital parametersPatient's preference regarding sedation and/or analgesics | Pain intensityDuration of colonoscopyVital parametersSedation score (RSS)Number of polypsConsumption of alfentanil and midazolamCaecal intubation rateInsertion time | Recalled worst pain intensity and patient satisfactionPreference for music during future colonoscopyView on whether music was relaxing (only the intervention group) |
RSS=Ramsay Sedation Score
The primary outcomes were pain intensity measured on a numerical rating scale (NRS) from 0=no pain and to 10=worst possible pain at T2 when the scope passes the splenic flexure and duration of the colonoscopy (minutes). Secondary outcomes were anxiety level at T1 measured on a visual analogue scale (VAS) from 0=no anxiety to 10=worst imaginable anxiety, level of sedation on Ramsay Sedation Score (RSS), consumption of alfentanil (mg/kg) and midazolam (mg/kg) at T2, vital signs at T1 and T2: mean arterial blood pressure (MAP) (mmHg), pulse (heartbeats/minute) and oxygen saturation (%). Moreover, caecal intubation rate (CIR) was recorded at T2—this is the percentage of success with which a gastroenterologist advances the colonoscope to the cecum. Recalled worst pain intensity during the colonoscopy (NRS 0-10) and patient satisfaction with the colonoscopy (on a five-point Likert scale) were recorded at T3.
Statistical analysis
The sample size was based on an expected difference of 1 on the NRS with 80% power (α=0.05, β=0.2) and standard deviation (SD) of 3.25. A sample size of 166 per group was required, ie, a total of 332 patients.
Data were tested for normal distribution using histograms and QQ-plots. Results are presented as mean + SD (parametric data) or frequencies or medians with interquartile range (IQR) (non-parametric data) as appropriate. Parametric data were compared using independent samples t-test and the Mann-Whitney U test was used for non-parametric data. Categorical data were analysed using χ2 test or Fisher exact test if any cells had expected counts less than five. All P values are two sided and those below 0.05 were considered significant. Intention-to-treat analysis was performed.
REDCap (Research Electronic Data Capture, Aarhus University, Denmark) was used for double entry, and statistical analyses were performed with Stata software, version 15.0 (StataCorp, USA).
Results
In all, 337 patients were randomised: 169 to the intervention group and 168 to the control group (Figure 1). Baseline characteristics (gender, age, weight and abdominal pain) were comparable between the two groups (Table 2).
Table 2. Baseline characteristics
| Baseline characteristics at T0 | Intervention group n=169 | Control group n=168 | P value |
|---|---|---|---|
| Gender, n (%) | 0.87 | ||
| Female | 81 (47.9) | 79 (47.0) | |
| Male | 88 (52.1) | 89 (53.0) | |
| Missing | 0 | 0 | |
| Age (years), mean (SD) | 56 (13.9) | 59 (13.2) | 0.07 |
| Missing | 1 | 1 | |
| Weight (kg), mean (SD) | 80 (19.1) | 80 (16.2) | 0.99 |
| Missing | 1 | 1 | |
| Abdominal pain, median (IQR) | 0 (0–0) | 0 (0–0) | 0.48 |
| Missing | 8 | 5 |
There was no significant difference in the pain intensity between the intervention group and the control group when passing the splenic flexure with the scope (3 (IQR 1-5) vs 3 (1-5), P=0.53). Furthermore, when stratifying according to gender, no significant differences were found although women tended to have a higher pain intensity: females (intervention group 4 (2-6) vs control group 3 (1-5), P=0.05) and males (intervention group 2 (0-4) vs control group 2 (0-4), P=0.37).
The differences in the insertion time (10 (7-15) vs 11 (8-14) minutes, P=0.18) and the overall duration of the colonoscopy (20 (16-31) vs 23 (17-35) minutes, P=0.07) between the intervention and the control group were statistically insignificant.
No significant difference in the level of anxiety was found between the intervention group and control group before the colonoscopy (2.3 (1.0-4.7) vs 2.5 (0.9-5.0), P=0.60). The two groups received similar treatment with both alfentanil (0.006 (0.003-0.011) mg/kg vs 0.006 (0.002-0.011) mg/kg, P=0.10) and midazolam (0.022 (0.011-0.029) mg/kg vs 0.021 (0.011-0.029) mg/kg, P=0.45) in the intervention group vs the control group and during colonoscopy the two groups had a similar Ramsay Sedation Score (RSS-score) (2 (1-6) vs 2 (1-6), P=0.21).
At T1, patients in the intervention group had a lower MAP (107 mmHg (95% CI 105-109 mmHg) vs 110 mmHg (95% CI 108-112 mmHg), P=0.03). When stratifying according to gender, differences were found between males (intervention group 107 mmHg (95% CI 104-110 mmHg) vs control group 112 mmHg (95% CI 109-115 mmHg), P=0.02) and females (intervention group 106 mmHg (95% CI 103-109 mmHg) vs control group 108 mmHg (95%CI 104-111 mmHg), P=0.54). Moreover, males in the intervention group had a lower pulse before the colonoscopy than men in the control group: males (intervention group 73 beats/minute (95% CI 70-76 beats/minute) vs control group 78 (95% CI 75-82 beats/minute), P=0.03). No differences were detected in the other vital parameters (oxygen saturation, pulse during colonoscopy or MAP during colonoscopy).
The worst recalled pain intensity during the colonoscopy was similar between the intervention group and control group (4 (IQR 2-8) vs 4 (2-6), P=0.31).
A very high patient satisfaction level was found in both the intervention group (5 (IQR 5-5)) and in the control group (5 (5-5)), P=0.63). In the intervention group, 78.7% of patients (n=133) would prefer to listen to music during a future colonoscopy if given the choice. In the control group, 32.7% (n=55) of the patients said they would prefer listening to music during a future colonoscopy. In the intervention group, 82.8% (n=140) found that the music helped them to relax.
Both groups had a high CIR: 92.9% in the intervention group vs 90.5% in the control group (P=0.95). The number of removed polyps per patient (0 (0-1)) vs (0 (0-1), P=0.47) and the number of suspected cancer signs (n=10 (5.9%) vs n=10 (6.0%), P=0.47) were similar between the intervention group and control group.
Discussion
To the authors' knowledge this is the first study to examine the effect of a music intervention with MusiCure in patients undergoing a colonoscopy. The primary aims of the study were to evaluate the effect of a music intervention with MusiCure music regarding pain intensity and duration of the colonoscopy. In accordance with several other studies, it was not possible to find an association between MusiCure music and a decrease in pain intensity and duration of the colonoscopy (Bechtold et al, 2009; Nilsson et al, 2009; Bashiri et al, 2018; Ko et al, 2019; Sorkpor et al, 2021). The lack of difference between groups can be attributed to low pain intensity score in both groups. Two systematic reviews and meta-analyses show that a music intervention has a statistically non-significant small effect on pain during a colonoscopy (Bechtold et al, 2009; Sorkpor et al, 2021). Both studies found a high heterogeneous effect and emphasised that the available evidence did not demonstrate consistent results in favour of music-induced analgesia in adults undergoing colonoscopy (Sorkpor et al, 2021). In contrast, two other studies, a systematic review and meta-analysis by Wang et al (2014) and a meta-analysis by Heath et al (2019), showed that a music intervention during colonoscopy reduced pain.
The findings of the present study are contrary to the marginally significant reduction in the use of sedation in the music group in the meta-analysis by Tam et al (2008). However, the findings reflect those of Nilsson et al (2009) and Bechtold et al (2009) who also found no significant differences between groups regarding consumption of analgesia and sedatives (Bechtold et al, 2009; Nilsson et al, 2009). This result might be explained by the low amounts of analgesia and sedatives.
Unlike other studies, the present study was unable to estimate an effect of a music intervention before the colonoscopy on the anxiety level (Palakanis et al, 1994; López-Cepero Andrada et al, 2004; Ovayolu et al, 2006; El-Hassan et al, 2009; Çelebi et al, 2020). There are several possible explanations for this result, including the time of assessment and choice of assessment tool. In the present study, the anxiety level was only measured before colonoscopy and not after. As with the pain intensity score, the lack of difference between groups can be attributed to low levels of anxiety in both groups. Furthermore, the authors chose to rate the level of anxiety on a VAS whereas many studies have chosen the validated Spielberger State-Trait Anxiety Inventory (STAI). These factors may have contributed to why the present study was not able to measure a difference in the anxiety level. As shown by Jeppesen et al (2019), the type of music may also have contributed to the lack of impact on the anxiety level since the person's preference has a big impact on the effect of the music intervention on the level of anxiety.
The study did find a small non-significant difference between groups regarding CIR. This finding is supported by Li et al (2019) who found that the endoscopist's perceived colonoscope insertion difficulty decreased in the music group. This supports the patients' statement of feeling more calm when listening to music, enabling the endoscopist to perform the colonoscopy more easily. Furthermore, as in two other studies (Salmore and Nelson, 2000; Smolen et al, 2002), the present study was able to show a significant but not clinically relevant decrease in pulse and blood pressure, supporting patients' statements.
In accordance with the present study, a previous study also found a gender difference, showing a tendency for a higher degree of relaxation among men in the intervention group than among the men in the control group (Björkman et al, 2013). But unlike the present study, the previous study also found a reduced anxiety level in women in the intervention group. Given that relaxation, overall experience, and patient satisfaction are very closely related to the experience of wellbeing, it gives a clear indication of the efficacy of music in reducing discomfort during colonoscopy, in both genders. Other studies have also shown a decrease in the cortisol level and facial electromyography activity indicating a lower stress level (Hayes et al, 2003; Walter et al, 2020). Future research should therefore be undertaken investigating these variables and possible gender differences.
Although it was not possible to show significant differences between groups in several of the outcomes, the authors found a high patient satisfaction. In line with these findings, many studies have shown a decrease in discomfort and an increase in patient and procedure satisfaction, patient co-operation, and preference for music during any future colonoscopy. Even though patient satisfaction and patient experience are of great importance for the patient and perhaps also the endoscopist, the outcome and the overall experience of the colonoscopy can be very difficult to estimate. This study adds to the growing body of research indicating that a music intervention has an impact on the patient experience during a colonoscopy.
The inconsistency in the literature may be due to several reasons, including the genre of music chosen, the duration of music intervention, the type of delivery, the frequency of exposure to the music, the characteristics of music and the experience level of the endoscopist. It is likely that the effect of the music is dependent on the individual's preference as shown by Jeppesen et al (2019) who found that self-selected music reduced anxiety. Music appears to have a bigger impact on pain intensity, anxiety level and so on when the patient chooses what music to hear during a procedure (Jeppesen et al, 2019) and brain research indicates that music is processed differently in the brain depending on an individual's musical background and competence (Caldwell and Riby, 2007; McClurkin and Smith, 2016). This might explain why patients in the two music groups in the study by Jeppesen et al (2019) were equally satisfied with the sound but varied in changes in anxiety.
Table 3. Gender differences in outcomes
| Time point | Intervention group n=169 | Control group n=168 | ||||
|---|---|---|---|---|---|---|
| Variable | Women (n=81) | Men (n=88) | Women (n=79) | Men (n=89) | P value | |
| T1 | MAP, mean (SD) | 108 (14.96) | 112 (13.52) | 106 (13.41) | 107 (11.94) | Men: 0.02* |
| Missing (%) | 8 (9.9) | 7 (8.0) | 2 (2.5) | 6 (6.7) | Women: 0.54 | |
| Pulse, mean (SD) | 76 (11.7) | 73 (14.0) | 77 (15.5) | 78 (15.0) | Men: 0.03* | |
| Missing (%) | 4 (4.9) | 4 (4.5) | 3 (3.8) | 7 (7.9) | Women: 0.61 | |
| Saturation, median (IQR) | 99 (97–100) | 98 (97–99) | 99 (97–100) | 98 (97–99) | Men: 0.18 | |
| Missing (%) | 3 (3.7) | 4 (4.5) | 3 (3.8) | 7 (7.9) | Women: 0.79 | |
| Anxiety, median (IQR) | 3,6 (1.2–5.7) | 1.7 (0.7–3,2) | 4.0 (1.2–6.0) | 1.9 (0.6–4.2) | Men: 0.43 | |
| Missing (%) | 2 (2.5) | 2 (2.3) | 2 (2.5) | 6 (6.7) | Women: 0.88 | |
| T2 | MAP, mean (SD) | 102 (14.50) | 104 (13.91) | 101 (17.18) | 107 (15.30) | Men: 0.10 |
| Missing (%) | 10 (12.3) | 5 (5.7) | 11 (13.9) | 12 (13.5) | Women: 0.77 | |
| Pulse, mean (SD) | 74 (14.38) | 71 (13.12) | 73 (16.35) | 75 (13.47) | Men: 0.10 | |
| Missing (%) | 7 (8.6) | 5 (5.7) | 6 (7.6) | 7 (7.9) | Women: 0.68 | |
| Saturation, median (SD) | 98 (96–99) | 97 (95–98) | 98 (96–99) | 97 (95–99) | Men: 0.99 | |
| Missing (%) | 7 (8.6) | 5 (5.7) | 7 (8.9) | 7 (7.9) | Women: 0.31 | |
| Pain intensity, median (IQR) | 4 (2–6) | 2 (0–4) | 3 (1–5) | 2 (0–4) | Men: 0.37 | |
| Missing (%) | 4 (4.9) | 4 (4.5) | 5 (6.3) | 8 (9.0) | Women: 0.05 | |
| Duration, median (IQR) | 11 (8–15) | 9 (6–14,5) | 11 (8–14) | 9 (7–15) | Men: 0.09 | |
| Missing (%) | 8 (9.9) | 4 (4.5) | 4 (5.1) | 10 (11.2) | Women: 0.79 | |
| Caecal intubation rate, n (%) | Men: 0.33 | |||||
| Yes | 73 (90.1) | 84 (95.5) | 72 (91.1) | 80 (89.9) | Women: 0.41 | |
| No | 7 (8.6) | 2 (2.3) | 5 (6.3) | 4 (4.5) | ||
| Missing | 1 (1.2) | 2 (2.3) | 2 (2.5) | 5 (5.6) | ||
| T3 | Prefer music during | Men: <0.01* | ||||
| colonoscopy, n (%) | Women: <0.01* | |||||
| Undecided | 4 (4.9) | 9 (10.2) | 23 (29.1) | 34 (38.2) | ||
| No | 4 (4.9) | 12 (13.6) | 19 (24.1) | 25 (28.1) | ||
| Yes | 70 (86.4) | 63 (71.6) | 32 (40.5) | 23 (25.8) | ||
| Missing | 3 (3.7) | 4 (4.5) | 5 (6.3) | 7 (7.9) | ||
| Recalled pain, median (IQR) | 6 (4–8) | 4 (1–5) | 5 (3–7) | 3 (2–5) | Men: 0.84 | |
| Missing (%) | 7 (8.6) | 5 (5.7) | 12 (15.2) | 7 (7.9) | Women: 0.15 | |
IQR=interquartile range; MAP=mean arterial pressure; SD=standard deviation
It is important to note that despite the inconsistency, patients in the present study and other studies reported increased patient satisfaction, including a feeling of calm and relaxation and a desire for the same protocol for recurrent procedures (Bechtold et al, 2009; Björkman et al, 2013; Martindale et al, 2014; Bashiri et al, 2018; Ko et al, 2019; Walter et al, 2020).
Some limitations with the present study must be considered. First, the choice of a VAS to measure the anxiety level, which made it difficult to compare results with other studies since the majority of studies have chosen to use the short version of the validated STAI. Second, the anxiety level was only measured once. Third, it was not possible to blind either the patients or the health professionals. Moreover, measuring the cortisol level could have provided extra evidence regarding how calm and relaxed patients were feeling. Finally, it would be interesting in future studies to use the individual endoscopist's Key Performance Indicators in the randomisation process. Although some methodical issues exist, as described, the present study is distinguished by the large number of participants and successful randomisation. External validity is strengthened by the fact that the study was carried out in a daily clinical setting with standard care and treatment reflecting daily practice. Overall, the findings of the study can be generalised to colonoscopy-naïve adults undergoing an ambulatory colonoscopy.
Conclusion
The authors were unable to show an effect on the primary endpoints. However, a high patient satisfaction level was found in the music group and a decrease in males' blood pressure and pulse before the colonoscopy indicating a reduced stress level. This indicates that a music intervention is an easy and inexpensive non-pharmacological intervention that may increase the quality of patient care before and during a colonoscopy, especially when individual preferences are taken into account. Because patient experience is very important for evaluating the quality of patient care, this would be a fruitful area for future work.
KEY POINTS
- A music intervention is an easy and inexpensive non-pharmacological intervention that may increase the quality of patient care before and during a colonoscopy
- A decrease in males' blood pressure and pulse before the colonoscopy indicated a reduced stress level when listening to music in the waiting area
- The effect of a music intervention is likely to depend on the individual's preference—music has a bigger impact on pain intensity and anxiety level when the patient chooses the music they would like to hear during a procedure
CPD reflective questions
- Consider some of the reasons why patients experience different levels of stress, anxiety and pain during a colonoscopy
- Why might patients who feel anxious require more pain relief?
- Consider some of the ways to reduce stress and anxiety in patients about to undergo a colonoscopy. What methods are used in your area of work?
- Why might some patients benefit from a music intervention during a procedure?