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Assessment of the Effectiveness of Progressive Relaxation Techniques in Individuals With Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive Muscle Relaxation
Relaxative Music
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ulcerative Colitis focused on measuring Ulcerative colitis, Progressive relaxation techniques, Quality of Life, Sleep Quality, Anxiety, Disease activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Ege University Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Progressive Relaxation Group

Relaxative Music Group

Control Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

"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
"IBD-QOL" scores
Increased "IBD-QOL" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
"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
" Disease Activity" scores
Increased "Disease Activity" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
March 15, 2023
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05788549
Brief Title
Assessment of the Effectiveness of Progressive Relaxation Techniques in Individuals With Ulcerative Colitis
Official Title
The Effect of Progressive Relaxation Techniques on Disease Activity, Anxiety, Sleep, and Quality of Life in Individuals With Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis, Progressive relaxation techniques, Quality of Life, Sleep Quality, Anxiety, Disease activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive Relaxation Group
Arm Type
Experimental
Arm Description
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
Arm Title
Relaxative Music Group
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Relaxative Music
Intervention Description
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
Primary Outcome Measure Information:
Title
"State and Trait Anxiety Inventory" scores
Description
Decreased "State and Trait Anxiety Inventory"scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
Time Frame
A total of two months of progressive relaxation techniques practice for each patient
Title
"IBD-QOL" scores
Description
Increased "IBD-QOL" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
Time Frame
A total of two months of progressive relaxation techniques practice for each patient
Title
"The Pittsburgh Sleep Quality Index" scores
Description
Increased "The Pittsburgh Sleep Quality Index" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
Time Frame
A total of two months of progressive relaxation techniques practice for each patient
Title
" Disease Activity" scores
Description
Increased "Disease Activity" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention
Time Frame
A total of two months of progressive relaxation techniques practice for each patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin YILDIRIM, Prof.
Organizational Affiliation
Ege University Faculty of Nursing
Official's Role
Study Chair
Facility Information:
Facility Name
Ege University Faculty of Nursing
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of the Effectiveness of Progressive Relaxation Techniques in Individuals With Ulcerative Colitis

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