Clinical trial NCT05788549: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Progressive relaxation techniques
Quality of Life
Sleep Quality
Anxiety
Disease activity
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: "State and Trait Anxiety Inventory" scores
timeFrame: A total of two months of progressive relaxation techniques practice for each patient
measure: "IBD-QOL" scores
timeFrame: A total of two months of progressive relaxation techniques practice for each patient
measure: "The Pittsburgh Sleep Quality Index" scores
timeFrame: A total of two months of progressive relaxation techniques practice for each patient
measure: " Disease Activity" scores
timeFrame: A total of two months of progressive relaxation techniques practice for each patient
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University Faculty of Nursing
Study officials:
affiliation: Ege University Faculty of Nursing
name: Yasemin YILDIRIM, Prof.
role: STUDY_CHAIR
References: