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Clinical Trials/NCT05708872
NCT05708872
Recruiting
Not Applicable

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

Maria Sklodowska-Curie National Research Institute of Oncology1 site in 1 country100 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colonic Neoplasms
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Enrollment
100
Locations
1
Primary Endpoint
Effect of methods of self-regulation of mental state on postoperative pain perception changes
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
December 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Effect of methods of self-regulation of mental state on mood changes(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(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.)

Study Sites (1)

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