To hear about similar clinical trials, please enter your email below
Trial Title:
The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients
NCT ID:
NCT05708872
Condition:
Colonic Neoplasms
Pain, Postoperative
Hypnotherapy
Conditions: Official terms:
Neoplasms
Colonic Neoplasms
Pain, Postoperative
Conditions: Keywords:
Colonic Neoplasms
Colorectal Neoplasms
Colectomy
Colorectal Surgery
Pain, Postoperative
Analgesics
Hypnosis
Autosuggestion
Mind-Body Therapies
Hypnotherapy
Psychotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Autohypnosis
Description:
Patients in the study group will receive a voice recording with hypnotic instructions
with a suggestion to improve the psychophysical state.
Arm group label:
Study group
Intervention type:
Behavioral
Intervention name:
Relaxing music
Description:
Patients in the control group will receive a recording with relaxing music
Arm group label:
Control group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Address:
City:
Gliwice
Zip:
44-102
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Marta Nowak-Kulpa
Phone:
+48 322788417
Email:
Marta.Nowak-Kulpa@io.gliwice.pl
Investigator:
Last name:
Marta Nowak-Kulpa
Email:
Principal Investigator
Investigator:
Last name:
Marcin Zeman
Email:
Principal Investigator
Start date:
October 1, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Maria Sklodowska-Curie National Research Institute of Oncology
Agency class:
Other
Source:
Maria Sklodowska-Curie National Research Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05708872
