Clinical trial NCT05708872: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Neoplasms
Pain, Postoperative
Hypnotherapy
Keywords: Colonic Neoplasms
Colorectal Neoplasms
Colectomy
Colorectal Surgery
Pain, Postoperative
Analgesics
Hypnosis
Autosuggestion
Mind-Body Therapies
Hypnotherapy
Psychotherapy
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of methods of self-regulation of mental state on postoperative pain perception changes
timeFrame: 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 outcomes:
measure: Effect of methods of self-regulation of mental state on mood changes
timeFrame: 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.
measure: Effect of methods of self-regulation of mental state on anxiety changes
timeFrame: 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.
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Study officials:
References: