Hypnotherapy and recovery after keyhole surgery for the gall bladder

ISRCTN	ISRCTN87316215
DOI	https://doi.org/10.1186/ISRCTN87316215
Protocol serial number	YOR-A01504
Sponsor	York Teaching Hospital NHS Foundation Trust (UK)
Funder	York Teaching Hospital NHS Foundation Trust (UK)

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

Department of Colorectal Surgery
4th Floor Administration Block
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom

Study information

Primary study design	Interventional
Study design	Single-centre parallel two-group randomised controlled trial
Secondary study design	Randomised parallel trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

York Hospital

York
YO31 8HE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/03/2020: Internal review.
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.