NCT05788549

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 15, 2023

Last Update Submit

March 15, 2023

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitisProgressive relaxation techniquesQuality of LifeSleep QualityAnxietyDisease activity

Outcome Measures

Primary Outcomes (4)

  • "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

  • "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

  • "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

  • " 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

Study Arms (3)

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

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

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

Interventions

Progressive Muscle RelaxationBEHAVIORAL

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

Progressive Relaxation Group
Relaxative MusicBEHAVIORAL

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

Relaxative Music Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Nursing

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 40243391DERIVED

MeSH Terms

Conditions

Colitis, UlcerativeSleep Initiation and Maintenance DisordersAnxiety Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Yasemin YILDIRIM, Prof.

    Ege University Faculty of Nursing

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, PhD student

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 29, 2023

Study Start

February 1, 2022

Primary Completion

December 30, 2022

Study Completion

May 31, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)