Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499909
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-06-11
Brief Title:
Hypnosis for Colectomies as Postoperative Pain Management
Sponsor:
Somerset NHS Foundation Trust
Organization:
Somerset NHS Foundation Trust
Study Overview
Official Title:
Hypnosis for the Management of Postoperative Pain Following Colectomies a Single Centre Randomised Controlled Feasibility Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hypnopal
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None