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

January 24, 2023 updated by: Maria Sklodowska-Curie National Research Institute of Oncology
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Gliwice, Poland, 44-102
        • Recruiting
        • Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
        • Contact:
        • Principal Investigator:
          • Marta Nowak-Kulpa
        • Principal Investigator:
          • Marcin Zeman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent to participate in the study
  2. Age >= 18 years
  3. Histopathological diagnosis of primary colon cancer without distant metastasis
  4. Planned surgical treatment
  5. Fluency in Polish

Exclusion Criteria:

  1. Severe comorbidities with pain disorders
  2. Regular use of analgesics
  3. Coexistence of another neoplastic disease
  4. Use of non-pharmacological pain management (including autohypnosis) prior to the study
  5. Poor general condition
  6. Previous colorectal surgery
  7. Hearing disorders
  8. No possibility of playback of the received recording

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control group
Behavioral: Relaxing music
Patients in the control group will receive a recording with relaxing music
EXPERIMENTAL: Study group
Behavioral: Autohypnosis
Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of methods of self-regulation of mental state on postoperative pain perception changes
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.

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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Effect of methods of self-regulation of mental state on mood changes
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.

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.
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.
Effect of methods of self-regulation of mental state on anxiety changes
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.

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:

  1. 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.
  2. 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

January 24, 2023

First Posted (ACTUAL)

February 1, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIOCHIR 01/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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