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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autohypnosis | Behavioral | Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of methods of self-regulation of mental state on mood changes | The timing of secondary 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. In terms of mood, the grade will be assessed using the following questions: 1. What mood is prevalent? A score of -10 means a maximal increase in mood; 0 state as usual (no change); and +10 means maximal state lowered. For all answers, higher scores mean a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Nowak-Kulpa | Contact | +48 322788417 | Marta.Nowak-Kulpa@io.gliwice.pl | |
| Marcin Zeman, MD, PhD | Contact | +48 322788417 | marcin.zeman@io.gliwice.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch | Recruiting | Gliwice | 44-102 | Poland |
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| Relaxing music | Behavioral | Patients in the control group will receive a recording with relaxing music |
|
| 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 timing of secondary 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. In terms of anxiety, the grade will be assessed using the following questions:
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. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D010149 | Pain, Postoperative |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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