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

NCT ID: NCT05708872

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Colonic Neoplasms Pain, Postoperative Hypnotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Study group

Group Type EXPERIMENTAL

Autohypnosis

Intervention Type BEHAVIORAL

Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state.

Control group

Group Type ACTIVE_COMPARATOR

Relaxing music

Intervention Type BEHAVIORAL

Patients in the control group will receive a recording with relaxing music

Interventions

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Autohypnosis

Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state.

Intervention Type BEHAVIORAL

Relaxing music

Patients in the control group will receive a recording with relaxing music

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

Gliwice, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Marta Nowak-Kulpa

Role: CONTACT

+48 322788417

Marcin Zeman, MD, PhD

Role: CONTACT

+48 322788417

Facility Contacts

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Marta Nowak-Kulpa

Role: primary

+48 322788417

Other Identifiers

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NIOCHIR 01/22

Identifier Type: -

Identifier Source: org_study_id

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