Ulcerative ColitisNCT05788549
Assessment of the Effectiveness of Progressive Relaxation Techniques in Individuals With Ulcerative Colitis
A study testing Progressive Muscle Relaxation and Relaxative Music in people with Ulcerative Colitis, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Ulcerative colitis is a chronic disease that follows a course of remission and flare-ups. Especially during flare-ups, the worsening of symptoms negatively affects all aspects of the individual's life and decreases their quality of life. Individuals sometimes have difficulty accessing healthcare facilities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Progressive Muscle Relaxation and Relaxative Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 31 May 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with UC at least six months ago
- Having been taking medication for at least three months
- Willingness to participate in the study
- Being 18 years of age or older
- Having been in remission for at least 3 months according to the partial Mayo score (Mayo score <2)
- Being able to use a computer, internet, and mobile phone
- Residing in Izmir or surrounding cities
- Being cooperative and able to communicate
Who cannot join
- Patients with advanced comorbid conditions such as cancer, diabetes, and chronic obstructive pulmonary disease have been excluded from the study due to the potential for more pronounced effects on symptoms and disease activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Relaxation Techniques on Disease Activity, Anxiety, Sleep, and Quality of Life in Individuals With Ulcerative Colitis
Ulcerative colitis is a chronic disease that follows a course of remission and flare-ups. Especially during flare-ups, the worsening of symptoms negatively affects all aspects of the individual's life and decreases their quality of life. Individuals sometimes have difficulty accessing healthcare facilities. In addition, every hospital admission causes an additional burden on healthcare institutions and the individual, both physically and financially. Therefore, it is of great importance to support and develop self-management behaviors for individuals to control their symptoms.
Progressive relaxation techniques are a relaxation method based on the principle of voluntary contraction and relaxation of muscle groups in our body. It has been reported that progressive relaxation techniques, which are applied in many chronic diseases and procedures, improve symptoms and disease parameters reported by individuals, especially pain, anxiety, and stress.
When the literature in the world and Turkey is examined, no study applying progressive relaxation techniques to ulcerative colitis patients has been encountered. It is known that especially stress and anxiety affect the number and severity of flare-ups in ulcerative colitis patients. It is thought that this study will contribute to the self-management behaviors of ulcerative colitis patients in the rare diseases group for the Turkish population and fill the gap in the literature.
Read the detailed description
The purpose of the research is to investigate the effect of progressive relaxation techniques on disease clinical activity, anxiety, sleep, and quality of life in individuals with ulcerative colitis.
We assigned 56 patients who met the inclusion criteria to the progressive relaxation group, the relaxing music group, and the control group using stratified randomization. The intervention (progressive relaxation) group was provided with a booklet and shown a video about progressive relaxation techniques.For the placebo (relaxing music) group, music from MusiCure, which consists of sounds of nature, was played. Reminder SMS messages were sent twice a week to the intervention and placebo groups. No intervention was administered to the control group.Forms were filled out again by individuals in the intervention, placebo, and control groups at the fourth and eighth week.
- Conditions
- Ulcerative Colitis
- Being tested
- Progressive Muscle Relaxation, Relaxative Music
- Keywords
- Ulcerative colitis, Progressive relaxation techniques, Quality of Life, Sleep Quality, Anxiety, Disease activity
- Medical subject headings
- Colitis, Ulcerative, Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationBehavioural
The Individual Identification Form, Partial Mayo Score, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and IBD-QOL were filled out in person during the first meeting. The first application was done face to face with the researcher. Individuals were asked to perform subsequent applications at home.Educational booklet describing the progressive relaxation exercises with pictures was given to individuals, and a video prepared by the researcher was uploaded to their mobile phones. Individuals were asked to practice progressive relaxation exercises every day, at least once a day, in a quiet and peaceful environment for 30-minute sessions. The researcher sent reminder SMS messages to individuals twice a week for eight weeks to encourage regular practice of the progressive relaxation exercises. Four and eight weeks after the first meeting, forms were transferred to an online environment and sent to individuals via WhatsApp Messenger as a link to be completed
Relaxative MusicBehavioural
The Individual Identification Form, Partial Mayo Score, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and IBD-QOL were filled out in person during the first meeting. Individuals were asked to perform subsequent applications at home.Individuals were provided with a relaxing music file prepared by the researcher and were asked to listen to it at least once a day for 30 minutes in a quiet and calm environment. The researcher also sent reminder SMS messages twice a week for eight weeks to remind individuals. Four and eight weeks after the first meeting, forms were transferred to an online environment and sent to individuals via WhatsApp Messenger as a link to be completed to listen to the relaxing music regularly. At 4 and 8 weeks after the first meeting, the researcher transferred the forms to an online environment via Google Forms and asked individuals to fill them out by accessing the link sent to them via WhatsApp Messenger
| Study group | Role | What they receive |
|---|---|---|
| Progressive Relaxation Group | Experimental | The Individual Identification Form, Partial Mayo Score, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and IBD-QOL were filled out in person during the first meeting. The first application was done face to face with the researcher. Individuals were asked to perform subsequent applications at home.Educational booklet describing the progressive relaxation exercises with pictures was given to individuals, and a video prepared by the researcher was uploaded to their mobile phones. Individuals were asked to practice progressive relaxation exercises every day, at least once a day, in a quiet and peaceful environment for 30-minute sessions. The researcher sent reminder SMS messages to individuals twice a week for eight weeks to encourage regular practice of the progressive relaxation exercises. Four and eight weeks after the first meeting, forms were transferred to an online environment and sent to individuals via WhatsApp Messenger as a link to be completed Receives: Behavioral: Progressive Muscle Relaxation |
| Relaxative Music Group | Placebo comparator | The Individual Identification Form, Partial Mayo Score, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and IBD-QOL were filled out in person during the first meeting. Individuals were asked to perform subsequent applications at home.Individuals were provided with a relaxing music file prepared by the researcher and were asked to listen to it at least once a day for 30 minutes in a quiet and calm environment. The researcher also sent reminder SMS messages twice a week for eight weeks to remind individuals. Four and eight weeks after the first meeting, forms were transferred to an online environment and sent to individuals via WhatsApp Messenger as a link to be completed to listen to the relaxing music regularly. At 4 and 8 weeks after the first meeting, the researcher transferred the forms to an online environment via Google Forms and asked individuals to fill them out by accessing the link sent to them via WhatsApp Messenger Receives: Behavioral: Relaxative Music |
| Control Group | No intervention | The Individual Identification Form, Partial Mayo Score, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and IBD-QOL were filled out in person during the first meeting.The members of this group have not undergone any intervention and continued their routine maintenance, treatment, and follow-up.At 4 and 8 weeks after the first meeting, the researcher transferred the forms to an online environment via Google Forms and asked individuals to fill them out by accessing the link sent to them via WhatsApp Messenger |
What is being measured
The primary outcome is the main question the study is designed to answer.
"State and Trait Anxiety Inventory" scores
Decreased "State and Trait Anxiety Inventory"scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
Measured: A total of two months of progressive relaxation techniques practice for each patient
"IBD-QOL" scores
Increased "IBD-QOL" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
Measured: A total of two months of progressive relaxation techniques practice for each patient
"The Pittsburgh Sleep Quality Index" scores
Increased "The Pittsburgh Sleep Quality Index" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
Measured: A total of two months of progressive relaxation techniques practice for each patient
" Disease Activity" scores
Increased "Disease Activity" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
Measured: A total of two months of progressive relaxation techniques practice for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Feb 2022
- Primary completion30 Dec 2022
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur ARTAN, Ege University
- Investigators
- Yasemin YILDIRIM, Prof., Study chair, Ege University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788549
- Sponsor's protocol ID
- 22-1T/50
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Techniques on Disease Activity, Anxiety, Sleep, and Quality of Life in Individuals With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05788549
- Acronym / sponsor ID
- 22-1T/50
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, Progressive relaxation techniques, Quality of Life, Sleep Quality, Anxiety, Disease activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 29 Mar 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.
Ulcerative colitis is a chronic disease that follows a course of remission and flare-ups. Especially during flare-ups, the worsening of symptoms negatively affects all aspects of the individual's life and decreases their quality of life. Individuals sometimes have difficulty accessing healthcare facilities. In addition, every hospital admission causes an additional burden on healthcare institutions and the individual, both physically and financially. Therefore, it is of great importance to support and develop self-management behaviors for individuals to control their symptoms.
Progressive relaxation techniques are a relaxation method based on the principle of voluntary contraction and relaxation of muscle groups in our body. It has been reported that progressive relaxation techniques, which are applied in many chronic diseases and procedures, improve symptoms and disease parameters reported by individuals, especially pain, anxiety, and stress.
When the literature in the world and Turkey is examined, no study applying progressive relaxation techniques to ulcerative colitis patients has been encountered. It is known that especially stress and anxiety affect the number and severity of flare-ups in ulcerative colitis patients. It is thought that this study will contribute to the self-management behaviors of ulcerative colitis patients in the rare diseases group for the Turkish population and fill the gap in the literature.
Detailed description
The purpose of the research is to investigate the effect of progressive relaxation techniques on disease clinical activity, anxiety, sleep, and quality of life in individuals with ulcerative colitis.
We assigned 56 patients who met the inclusion criteria to the progressive relaxation group, the relaxing music group, and the control group using stratified randomization. The intervention (progressive relaxation) group was provided with a booklet and shown a video about progressive relaxation techniques.For the placebo (relaxing music) group, music from MusiCure, which consists of sounds of nature, was played. Reminder SMS messages were sent twice a week to the intervention and placebo groups. No intervention was administered to the control group.Forms were filled out again by individuals in the intervention, placebo, and control groups at the fourth and eighth week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Progressive Relaxation Group | Experimental | Behavioral: Progressive Muscle RelaxationThe Individual Identification Form, Partial Mayo Score, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and IBD-QOL were filled out in person during the first meeting. The first application was done face to face with the researcher. Individuals were asked to perform subsequent applications at home.Educational booklet describing the progressive relaxation exercises with pictures was given to individuals, and a video prepared by the researcher was uploaded to their mobile phones. Individuals were asked to practice progressive relaxation exercises every day, at least once a day, in a quiet and peaceful environment for 30-minute sessions. The researcher sent reminder SMS messages to individuals twice a week for eight weeks to encourage regular practice of the progressive relaxation exercises. Four and eight weeks after the first meeting, forms were transferred to an online environment and sent to individuals via WhatsApp Messenger as a link to be completed |
| Relaxative Music Group | Placebo comparator | Behavioral: Relaxative MusicThe Individual Identification Form, Partial Mayo Score, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and IBD-QOL were filled out in person during the first meeting. Individuals were asked to perform subsequent applications at home.Individuals were provided with a relaxing music file prepared by the researcher and were asked to listen to it at least once a day for 30 minutes in a quiet and calm environment. The researcher also sent reminder SMS messages twice a week for eight weeks to remind individuals. Four and eight weeks after the first meeting, forms were transferred to an online environment and sent to individuals via WhatsApp Messenger as a link to be completed to listen to the relaxing music regularly. At 4 and 8 weeks after the first meeting, the researcher transferred the forms to an online environment via Google Forms and asked individuals to fill them out by accessing the link sent to them via WhatsApp Messenger |
| Control Group | No intervention | –The Individual Identification Form, Partial Mayo Score, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and IBD-QOL were filled out in person during the first meeting.The members of this group have not undergone any intervention and continued their routine maintenance, treatment, and follow-up.At 4 and 8 weeks after the first meeting, the researcher transferred the forms to an online environment via Google Forms and asked individuals to fill them out by accessing the link sent to them via WhatsApp Messenger |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Having been diagnosed with UC at least six months ago
- Having been taking medication for at least three months
- Willingness to participate in the study
- Being 18 years of age or older
- Having been in remission for at least 3 months according to the partial Mayo score (Mayo score <2)
Key exclusion criteria (1 listed)
- Patients with advanced comorbid conditions such as cancer, diabetes, and chronic obstructive pulmonary disease have been excluded from the study due to the potential for more pronounced effects on symptoms and disease activity.
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 |
|---|---|---|
| Progressive Muscle RelaxationThe Individual Identification Form, Partial Mayo Score, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and IBD-QOL were filled out in person during the first meeting. The first application was done face to face with the researcher. Individuals were asked to perform subsequent applications at home.Educational booklet describing the progressive relaxation exercises with pictures was given to individuals, and a video prepared by the researcher was uploaded to their mobile phones. Individuals were asked to practice progressive relaxation exercises every day, at least once a day, in a quiet and peaceful environment for 30-minute sessions. The researcher sent reminder SMS messages to individuals twice a week for eight weeks to encourage regular practice of the progressive relaxation exercises. Four and eight weeks after the first meeting, forms were transferred to an online environment and sent to individuals via WhatsApp Messenger as a link to be completed | Behavioural | Progressive Relaxation Group |
| Relaxative MusicThe Individual Identification Form, Partial Mayo Score, State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and IBD-QOL were filled out in person during the first meeting. Individuals were asked to perform subsequent applications at home.Individuals were provided with a relaxing music file prepared by the researcher and were asked to listen to it at least once a day for 30 minutes in a quiet and calm environment. The researcher also sent reminder SMS messages twice a week for eight weeks to remind individuals. Four and eight weeks after the first meeting, forms were transferred to an online environment and sent to individuals via WhatsApp Messenger as a link to be completed to listen to the relaxing music regularly. At 4 and 8 weeks after the first meeting, the researcher transferred the forms to an online environment via Google Forms and asked individuals to fill them out by accessing the link sent to them via WhatsApp Messenger | Behavioural | Relaxative Music Group |
Primary outcome
"State and Trait Anxiety Inventory" scores
Time frame: A total of two months of progressive relaxation techniques practice for each patient
Decreased "State and Trait Anxiety Inventory"scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
"IBD-QOL" scores
Time frame: A total of two months of progressive relaxation techniques practice for each patient
Increased "IBD-QOL" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
"The Pittsburgh Sleep Quality Index" scores
Time frame: A total of two months of progressive relaxation techniques practice for each patient
Increased "The Pittsburgh Sleep Quality Index" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
" Disease Activity" scores
Time frame: A total of two months of progressive relaxation techniques practice for each patient
Increased "Disease Activity" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- 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.
Yasemin YILDIRIM, Prof. study chair
Ege University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation and Relaxative Music in people with Ulcerative Colitis, run by Ege University at 1 site in Turkey (Türkiye).
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 8 inclusion and 1 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 29 Mar 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"State and Trait Anxiety Inventory" scores (time frame: A total of two months of progressive relaxation techniques practice for each patient). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05788549, which also lists 1 linked publication.
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 29 Mar 2023.