to Evaluate the Effects of Clinical Hypnosis on Post-operative Pain, Following Colectomy OperationsHypnopalNCT06499909
Hypnosis for Colectomies as Postoperative Pain Management
A study testing Hypnosis in people with to Evaluate the Effects of Clinical Hypnosis on Post-operative Pain, Following Colectomy Operations, run by Somerset NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The present study intends to assess the feasibility, value and direction of conducting a future, full scale randomised controlled trial, to evaluate the effects of clinical hypnosis on post-operative pain, following colectomy operations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- to Evaluate the Effects of Clinical Hypnosis on Post-operative Pain, Following Colectomy Operations
- What is being tested?
- Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be included in the study if they meet ALL of the following inclusion criteria
- Aged 18 years or over;
- Undergoing elective colectomy surgery (open and laparoscopic colectomies will be included).
- Patients that can provide written informed consent.
- Are able to understand and communicate in English.
Who cannot join
- A patient meeting ANY of the following exclusion criteria at baseline will be excluded from participation:
- Emergency colectomies will be excluded due to the urgency of the intervention.
- Non English speakers.
- Patients with the following diagnosed mental health illness: personality disorders, psychosis or schizophrenia as hypnosis could aggravate these conditions.
- Patients that are already involved in other research studies and that could influence the results of the study.
- Any patient that is clinically unwell post-surgery with a National Early Warning Score (NEWS) of 5 or higher. NEWSscore is a tool developed for NHS England which improves the detection and response to clinical deterioration in adult patients and is a key element of patient safety and improving patient outcomes.
- Patients with deafness or difficulty hearing as this would be essential for this therapy to be effective.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Somerset NHS Foundation Trust
Taunton, Somerset, TA4 3RF
About this study
Official title: Hypnosis for the Management of Postoperative Pain Following Colectomies: a Single Centre Randomised Controlled Feasibility Trial
The present study intends to assess the feasibility, value and direction of conducting a future, full scale randomised controlled trial, to evaluate the effects of clinical hypnosis on post-operative pain, following colectomy operations.
Pain management in the postoperative setting presents a challenge as the development and severity of pain after surgery is dependent on different patient and procedural factors. Furthermore, pain after surgery is a major concern for patients, especially when it is undermanaged. When postoperative pain control is suboptimal it delays mobilisation, reduces oral food and fluid intake after surgery, and increases the risk of developing chronic pain and other complications. These factors have a negative impact on the patient recovery process, thus increasing the length of hospital stay and healthcare costs. Hypnosis is well recognised as having an effect in pain perception, it is a brief, easy to administer intervention making it a promising non-pharmacological intervention with the potential to help postoperative pain management in patients undergoing colectomies as well as reducing anxiety and emotional stress related to surgery, while also having a positive indirect effect on recovery times, which could lead to considerable cost-savings at organisational level.
The intervention will be delivered at Somerset NHS Foundation Trust by a designated Principal Investigator. Hypnosis sessions will be given face to face in a clinical consulting room and on the ward where the participants will be admitted after surgery. The study aims to enrol 40 participants, 20 for each arm, over 12 months, from Musgrove Park Hospital who will undergo elective colectomy surgery. Eligible participants would be adults 18 years or over, undergoing elective colectomy surgery. Participants must be able to provide a written informed consent and able to understand and communicate in English.
- Conditions
- to Evaluate the Effects of Clinical Hypnosis on Post-operative Pain, Following Colectomy Operations
- Being tested
- Hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
The patient will receive a course of hypnosis
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | Patient receives hypnosis treatment prior to surgery Receives: Other: Hypnosis |
| Normal care pathway | No intervention | Patient will receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of hypnotic analgesia on post-operative pain after colectomies.
The investigator is assessing the effectiveness of hypnosis on pain by using numeric pain scales to assess pain scores before and after hypnosis. This will then help the investigator evaluate pain scores between groups and compare the before and after hypnosis scores.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start6 Jun 2023
- Primary completion29 Feb 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for to Evaluate the Effects of Clinical Hypnosis on Post-operative Pain, Following Colectomy OperationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somerset NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499909
- Sponsor's protocol ID
- 303418
- Acronym
- Hypnopal
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toth AM, Mackey P, Donato SD, Alcacer-Pitarch B. Hypnosis for Postoperative Pain Management Following Colectomies: A Single-Center Randomized Controlled Feasibility Trial. Dis Colon Rectum. 2026 Aug 27. doi: 10.1097/DCR.0000000000004384. Online ahead of print.
PubMed 42657589
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis for the Management of Postoperative Pain Following Colectomies: a Single Centre Randomised Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT06499909
- Acronym / sponsor ID
- Hypnopal / 303418
- Conditions
- to Evaluate the Effects of Clinical Hypnosis on Post-operative Pain, Following Colectomy Operations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Somerset NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study intends to assess the feasibility, value and direction of conducting a future, full scale randomised controlled trial, to evaluate the effects of clinical hypnosis on post-operative pain, following colectomy operations.
Pain management in the postoperative setting presents a challenge as the development and severity of pain after surgery is dependent on different patient and procedural factors. Furthermore, pain after surgery is a major concern for patients, especially when it is undermanaged. When postoperative pain control is suboptimal it delays mobilisation, reduces oral food and fluid intake after surgery, and increases the risk of developing chronic pain and other complications. These factors have a negative impact on the patient recovery process, thus increasing the length of hospital stay and healthcare costs. Hypnosis is well recognised as having an effect in pain perception, it is a brief, easy to administer intervention making it a promising non-pharmacological intervention with the potential to help postoperative pain management in patients undergoing colectomies as well as reducing anxiety and emotional stress related to surgery, while also having a positive indirect effect on recovery times, which could lead to considerable cost-savings at organisational level.
The intervention will be delivered at Somerset NHS Foundation Trust by a designated Principal Investigator. Hypnosis sessions will be given face to face in a clinical consulting room and on the ward where the participants will be admitted after surgery. The study aims to enrol 40 participants, 20 for each arm, over 12 months, from Musgrove Park Hospital who will undergo elective colectomy surgery. Eligible participants would be adults 18 years or over, undergoing elective colectomy surgery. Participants must be able to provide a written informed consent and able to understand and communicate in English.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Other: HypnosisPatient receives hypnosis treatment prior to surgery |
| Normal care pathway | No intervention | –Patient will receive standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients will be included in the study if they meet ALL of the following inclusion criteria
- Aged 18 years or over;
- Undergoing elective colectomy surgery (open and laparoscopic colectomies will be included).
- Patients that can provide written informed consent.
- Are able to understand and communicate in English.
Key exclusion criteria (7 listed)
- A patient meeting ANY of the following exclusion criteria at baseline will be excluded from participation:
- Emergency colectomies will be excluded due to the urgency of the intervention.
- Non English speakers.
- Patients with the following diagnosed mental health illness: personality disorders, psychosis or schizophrenia as hypnosis could aggravate these conditions.
- Patients that are already involved in other research studies and that could influence the results of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnosisThe patient will receive a course of hypnosis | Other | Hypnosis |
Primary outcome
The effectiveness of hypnotic analgesia on post-operative pain after colectomies.
Time frame: 365 days
The investigator is assessing the effectiveness of hypnosis on pain by using numeric pain scales to assess pain scores before and after hypnosis. This will then help the investigator evaluate pain scores between groups and compare the before and after hypnosis scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 42657589Toth AM, Mackey P, Donato SD, Alcacer-Pitarch B. Hypnosis for Postoperative Pain Management Following Colectomies: A Single-Center Randomized Controlled Feasibility Trial. Dis Colon Rectum. 2026 Aug 27. doi: 10.1097/DCR.0000000000004384. Online ahead of print.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with to Evaluate the Effects of Clinical Hypnosis on Post-operative Pain, Following Colectomy Operations, run by Somerset NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of hypnotic analgesia on post-operative pain after colectomies. (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06499909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.