The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 1, 2023
December 1, 2022
2.2 years
December 27, 2022
January 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of methods of self-regulation of mental state on postoperative pain perception changes
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 Outcomes (2)
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 Arms (2)
Study group
EXPERIMENTALControl group
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, 44-102, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2022
First Posted
February 1, 2023
Study Start
October 1, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
February 1, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share