Hypnotherapy and recovery after keyhole surgery for the gall bladder
| ISRCTN | ISRCTN87316215 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87316215 |
| Secondary identifying numbers | YOR-A01504 |
- Submission date
- 22/10/2010
- Registration date
- 03/12/2010
- Last edited
- 16/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr David J. Alexander
Scientific
Scientific
Department of Colorectal Surgery
4th Floor Administration Block
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
Study information
| Study design | Single-centre parallel two-group randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Pre-operative hypnotherapy and recovery after laparoscopic cholecystectomy: a randomised controlled trial |
| Study objectives | Participants randomised to receive a single session of taped self-hypnosis prior to keyhole surgery to remove the gall bladder will have lower pain levels 24 hours after surgery than participants who listen to a tape of white noise prior to their surgery. |
| Ethics approval(s) | East Yorkshire and North Lincolnshire Research Ethics Committee (part of the UK 's NHS National Research Ethics Service), 31/08/2010, ref: 10/H1304/21 |
| Health condition(s) or problem(s) studied | Surgical removal of the gall bladder for the treatment of cholelithiasis (gallstones) or cholecystitis (inflammation of the gall bladder) |
| Intervention | 1. Audiotape of hypnotherapy (created and recorded by an experienced clinical hypnotherapist) 2. Audiotape of white noise (white noise produced by combining sounds of all different frequencies together. White noise is frequently used to mask other sounds especially unpleasant or unwanted sounds. Can be used therapeutically.) Duration of intervention is an hour (listen to hypnotherapy tape or tape of white noise on one occasion prior to surgery - each tape lasts about an hour). Duration of follow up is 4 months. |
| Intervention type | Other |
| Primary outcome measure | Pain using a numeric pain scale where 0 is 'no pain' and 10 is 'worst pain imaginable'. Primary outcome is level of pain 24 hours after surgery. |
| Secondary outcome measures | 1. Pain using a numeric pain scale where 0 is 'no pain' and 10 is 'worst pain imaginable'. Secondary pain outcomes measured at 4 hours, 4 days, 1 week, 2 weeks after surgery. 2. Use of pain relief medication in first two weeks after surgery 3. Blood pressure and heart rate measured on admission, at anaesthetic induction, 30 minutes into surgery, 30 minutes after regaining consciousness, 6 hours, 12 hours and 24 hours after surgery 4. Quality of life using the SF-36. Measured before surgery, day 1 after surgery, 1 week, 4 weeks and 4 months after surgery |
| Overall study start date | 01/12/2010 |
| Completion date | 01/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Aged 18 - 90 years, either sex 2. Diagnosis of cholelithiasis and/or cholecystitis 3. Requiring elective laparoscopic cholecystectomy 4. Under the care of two named surgeons at York Hospital |
| Key exclusion criteria | 1. Under the age of 18 or over the age of 90 years 2. Diagnosis of cholelithiasis but requiring an open cholecystectomy 3. Requiring surgery for reasons other than cholelithiasis and/or cholecystitis 4. Requiring emergency laparoscopic cholecystectomy 5. Received hypnosis within the past 3 months 6. Current and/or past history of psychiatric illness 7. Regular use of prescribed analgesics (i.e. on repeat prescription for analgesics) 8. Severe cognitive impairment 9. Hearing impairment (the study involves listening to audio tapes) 10. Not able to understand English |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 01/06/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
York Hospital
York
YO31 8HE
United Kingdom
YO31 8HE
United Kingdom
Sponsor information
York Teaching Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
York Hospital
Wigginton Road
York
YO31 8HE
England
United Kingdom
| Website | http://www.york.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/027e4g787 |
Funders
Funder type
Hospital/treatment centre
York Teaching Hospital NHS Foundation Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
16/03/2020: Internal review.
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.
