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The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients

Primary Purpose

Colonic Neoplasms, Pain, Postoperative, Hypnotherapy

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Autohypnosis
Relaxing music
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Neoplasms focused on measuring Colonic Neoplasms, Colorectal Neoplasms, Colectomy, Colorectal Surgery, Pain, Postoperative, Analgesics, Hypnosis, Autosuggestion, Mind-Body Therapies, Hypnotherapy, Psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent to participate in the study Age >= 18 years Histopathological diagnosis of primary colon cancer without distant metastasis Planned surgical treatment Fluency in Polish Exclusion Criteria: Severe comorbidities with pain disorders Regular use of analgesics Coexistence of another neoplastic disease Use of non-pharmacological pain management (including autohypnosis) prior to the study Poor general condition Previous colorectal surgery Hearing disorders No possibility of playback of the received recording

Sites / Locations

  • Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Effect of methods of self-regulation of mental state on postoperative pain perception changes
The timing of primary outcome measurement includes more than one time point because outcome measurements assess changes in patient status. The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery. The measure will assess the condition over the last 24 hours on scales ranging from -10 to +10 of the Activity Change Scale. For pain, the score will be reviewed by asking: 1. Which bodily sensations predominate at the site of the illness? A score of -10 indicates maximal relief; 0 neutral condition; and +10 indicates maximal pain. For all answers, higher scores mean a worse outcome.

Secondary Outcome Measures

Effect of methods of self-regulation of mental state on mood changes
The timing of secondary outcome measurement includes more than one time point because outcome measurements assess changes in patient status. The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery. The measure will assess the condition over the last 24 hours on scales ranging from -10 to +10 of the Activity Change Scale. In terms of mood, the grade will be assessed using the following questions: 1. What mood is prevalent? A score of -10 means a maximal increase in mood; 0 state as usual (no change); and +10 means maximal state lowered. For all answers, higher scores mean a worse outcome.
Effect of methods of self-regulation of mental state on anxiety changes
The timing of secondary outcome measurement includes more than one time point because outcome measurements assess changes in patient status. The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery. The measure will assess the condition over the last 24 hours on scales ranging from -10 to +10 of the Activity Change Scale. In terms of anxiety, the grade will be assessed using the following questions: What is the level of anxiety? A score of -10 means maximal calm; 0 state as usual (no change); and +10 means maximal high anxiety. How do you feel about the future? A score of -10 means maximum hope that things are going to work out; 0 status as usual (no change); and +10 means maximum anxiety about the future. For all answers, higher scores mean a worse outcome.

Full Information

First Posted
December 27, 2022
Last Updated
January 24, 2023
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT05708872
Brief Title
The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients
Official Title
The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, it will be investigated whether the methods of self-regulation of mental state have an effect on postoperative pain perception in colon cancer patients.
Detailed Description
According to the assumptions of psychoneuroimmunology, the improvement of mental state affects the physical improvement of patients. Numerous studies confirm the effectiveness of hypnosis and learning autohypnosis in improving the functioning of patients in terms of reducing pain and anxiety, improving the quality of sleep and mood. The study is a Prospective Randomized Controlled Trial consisting of two groups. Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state. Patients in the control group will receive a recording with relaxing music. Depending on the randomization, patients will listen to the selected recording before being admitted to the surgical department. They will then be given a recording to listen to whenever they want. The patients will be examined four times using the Activity Change Scale, ie. before randomization, on the first day after surgery, on the 7th day after surgery and 1 month after surgery. Simultaneously the total analgesic consumption will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Pain, Postoperative, Hypnotherapy
Keywords
Colonic Neoplasms, Colorectal Neoplasms, Colectomy, Colorectal Surgery, Pain, Postoperative, Analgesics, Hypnosis, Autosuggestion, Mind-Body Therapies, Hypnotherapy, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Autohypnosis
Intervention Description
Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state.
Intervention Type
Behavioral
Intervention Name(s)
Relaxing music
Intervention Description
Patients in the control group will receive a recording with relaxing music
Primary Outcome Measure Information:
Title
Effect of methods of self-regulation of mental state on postoperative pain perception changes
Description
The timing of primary outcome measurement includes more than one time point because outcome measurements assess changes in patient status. The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery. The measure will assess the condition over the last 24 hours on scales ranging from -10 to +10 of the Activity Change Scale. For pain, the score will be reviewed by asking: 1. Which bodily sensations predominate at the site of the illness? A score of -10 indicates maximal relief; 0 neutral condition; and +10 indicates maximal pain. For all answers, higher scores mean a worse outcome.
Time Frame
The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery.
Secondary Outcome Measure Information:
Title
Effect of methods of self-regulation of mental state on mood changes
Description
The timing of secondary outcome measurement includes more than one time point because outcome measurements assess changes in patient status. The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery. The measure will assess the condition over the last 24 hours on scales ranging from -10 to +10 of the Activity Change Scale. In terms of mood, the grade will be assessed using the following questions: 1. What mood is prevalent? A score of -10 means a maximal increase in mood; 0 state as usual (no change); and +10 means maximal state lowered. For all answers, higher scores mean a worse outcome.
Time Frame
The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery.
Title
Effect of methods of self-regulation of mental state on anxiety changes
Description
The timing of secondary outcome measurement includes more than one time point because outcome measurements assess changes in patient status. The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery. The measure will assess the condition over the last 24 hours on scales ranging from -10 to +10 of the Activity Change Scale. In terms of anxiety, the grade will be assessed using the following questions: What is the level of anxiety? A score of -10 means maximal calm; 0 state as usual (no change); and +10 means maximal high anxiety. How do you feel about the future? A score of -10 means maximum hope that things are going to work out; 0 status as usual (no change); and +10 means maximum anxiety about the future. For all answers, higher scores mean a worse outcome.
Time Frame
The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent to participate in the study Age >= 18 years Histopathological diagnosis of primary colon cancer without distant metastasis Planned surgical treatment Fluency in Polish Exclusion Criteria: Severe comorbidities with pain disorders Regular use of analgesics Coexistence of another neoplastic disease Use of non-pharmacological pain management (including autohypnosis) prior to the study Poor general condition Previous colorectal surgery Hearing disorders No possibility of playback of the received recording
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Nowak-Kulpa
Phone
+48 322788417
Email
Marta.Nowak-Kulpa@io.gliwice.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Marcin Zeman, MD, PhD
Phone
+48 322788417
Email
marcin.zeman@io.gliwice.pl
Facility Information:
Facility Name
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Nowak-Kulpa
Phone
+48 322788417
Email
Marta.Nowak-Kulpa@io.gliwice.pl
First Name & Middle Initial & Last Name & Degree
Marta Nowak-Kulpa
First Name & Middle Initial & Last Name & Degree
Marcin Zeman

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients

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