Hypnosis for Colectomies as Postoperative Pain Management

NCT ID: NCT06499909

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2024-04-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypnosis

Patient receives hypnosis treatment prior to surgery

Group Type: EXPERIMENTAL

Hypnosis

Intervention Type: OTHER

The patient will receive a course of hypnosis

Normal care pathway

Patient will receive standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hypnosis

The patient will receive a course of hypnosis

Intervention Type: OTHER

Eligibility Criteria

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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Somerset NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Somerset NHS Foundation Trust

Taunton, Somerset, United Kingdom

Countries

United Kingdom

Other Identifiers

303418

Identifier Type: -

Identifier Source: org_study_id