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

Ulcerative Colitis Clinical Trial

Official title:

The Effect of Progressive Relaxation Techniques on Disease Activity, Anxiety, Sleep, and Quality of Life in Individuals With Ulcerative Colitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05788549
• Other study ID #: 22-1T/50
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: March 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: May 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Behavioral:
• Progressive Muscle Relaxation
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 Music
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

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Nursing	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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	A total of two months of progressive relaxation techniques practice for each patient
Primary	"IBD-QOL" scores	Increased "IBD-QOL" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention	A total of two months of progressive relaxation techniques practice for each patient
Primary	"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	A total of two months of progressive relaxation techniques practice for each patient
Primary	" Disease Activity" scores	Increased "Disease Activity" scores of intervention group in follow-up measurements after progressive relaxation techniques intervention	A total of two months of progressive relaxation techniques practice for each patient