Colonic NeoplasmsNCT05708872
The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients
A study testing Autohypnosis and Relaxing music in people with Colonic Neoplasms and Pain, Postoperative, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Pain, Postoperative, Hypnotherapy
- What is being tested?
- Autohypnosis and Relaxing music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, 44-102
Marta Nowak-Kulpa, +48 322788417, Marta.Nowak-Kulpa@io.gliwice.pl
Marta Nowak-Kulpa
About this study
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.
Read the 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.
- Conditions
- Colonic Neoplasms, Pain, Postoperative, Hypnotherapy
- Being tested
- Autohypnosis, Relaxing music
- Keywords
- Colonic Neoplasms, Colorectal Neoplasms, Colectomy, Colorectal Surgery, Pain, Postoperative, Analgesics, Hypnosis, Autosuggestion, Mind-Body Therapies, Hypnotherapy, Psychotherapy
- Medical subject headings
- Colonic Neoplasms, Pain, Postoperative, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutohypnosisBehavioural
Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state.
Relaxing musicBehavioural
Patients in the control group will receive a recording with relaxing music
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Behavioral: Autohypnosis |
| Control group | Active comparator | Not described Receives: Behavioral: Relaxing music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: 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 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:
- 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.
Measured: 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:
- What is the level of anxiety? A score of -10 means maximal calm; 0 state as usual (no change); and +10 means maximal high anxiety.
- How do you feel about the future? A score of -10 means maximum hope that things are going to work out; 0 status as usual (no change); and +10 means maximum anxiety about the future.
For all answers, higher scores mean a worse outcome.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708872
- Sponsor's protocol ID
- NIOCHIR 01/22
- Status last verified
- Dec 2022
- First submitted
- 27 Dec 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients
- ClinicalTrials.gov ID
- NCT05708872
- Acronym / sponsor ID
- NIOCHIR 01/22
- Conditions
- Colonic Neoplasms, Pain, Postoperative, Hypnotherapy
- Keywords
- Colonic Neoplasms, Colorectal Neoplasms, Colectomy, Colorectal Surgery, Pain, Postoperative, Analgesics, Hypnosis, Autosuggestion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Autohypnosis |
| Control group | Active comparator | Behavioral: Relaxing music |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AutohypnosisPatients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state. | Behavioural | Study group |
| Relaxing musicPatients in the control group will receive a recording with relaxing music | Behavioural | Control group |
Primary outcome
Effect of methods of self-regulation of mental state on postoperative pain perception changes
Time frame: 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 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.
2 secondary outcomes
Effect of methods of self-regulation of mental state on mood changes
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autohypnosis and Relaxing music in people with Colonic Neoplasms and Pain, Postoperative, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Nowak-Kulpa (+48 322788417, Marta.Nowak-Kulpa@io.gliwice.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of methods of self-regulation of mental state on postoperative pain perception changes (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.