Condition category
Digestive System
Date applied
22/10/2010
Date assigned
03/12/2010
Last edited
11/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr David J. Alexander

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

YOR-A01504

Study information

Scientific title

Pre-operative hypnotherapy and recovery after laparoscopic cholecystectomy: a randomised controlled trial

Acronym

Study hypothesis

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

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

Study design

Single-centre parallel two-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cholelithiasis, cholecystitis

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/2010

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/12/2010

Recruitment end date

01/06/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

York Hospital
York
YO31 8HE
United Kingdom

Sponsor information

Organisation

York Teaching Hospital NHS Foundation Trust (UK)

Sponsor details

York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom

Sponsor type

Government

Website

http://www.york.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

York Teaching Hospital NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes