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 Oncology

Status: Enrolling

Conditions: Colonic Neoplasms; Pain, Postoperative; Hypnotherapy

Treatments: Behavioral: Autohypnosis; Behavioral: Relaxing music

Study type: Interventional

Funder types: Other

Identifiers

NCT05708872

NIOCHIR 01/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Study group

Experimental group

Treatment:

Behavioral: Autohypnosis

Control group

Active Comparator group

Treatment:

Behavioral: Relaxing music