NCT06079463

Brief Summary

Purpose of the study: The study aimed to direct the anxiety and quality of life of progressive movement exercise in diabetic patients. Type of research: A randomized controlled pre-test-post-test study was planned with the aim of directing progressive movement exercise on anxiety and quality of life in diabetics. research questions Q1: Does progressive movement exercise have an effect on diabetic anxiety and quality of life? Population of the Research and Sample Selection: The home of the research will be the diabetes windows to the internal service on data collection. G-power 3.1 analysis program environment to calculate large sample size. Sampling of the research; With 0.61% effect sizes, 0.05% error level, 95% confidence interval and 80% power to show the universe, 52 people took part in the experimental motivations (phased training exercises group) and 52 people took part in the control slots, for a total of 104 people. Sample selection criteria patients are randomized using the Random Integer Generator method from the Numbers subheading on the Random.org website. In randomization, aspects will be collected representatively of 1 experimental group and 2 control groups.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 10, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

July 5, 2023

Last Update Submit

August 28, 2024

Conditions

Keywords

AnxietyDiabetesExerciseQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Beck Anxiety Scale

    Progressive relaxation exercise was applied to the patients for 4 weeks. After the application, anxiety scores were determined with the Back Anxiety Scale and the results were recorded.

    4 weeks

Secondary Outcomes (1)

  • World Health Organization Quality of Life Scale

    4 weeks

Study Arms (2)

Diabetic patients undergoing progressive relaxation exercise

EXPERIMENTAL

After the purpose of the study was explained and their verbal and written consents were obtained, a questionnaire including the Beck Anxiety Scale, which includes the socio-demographic characteristics, and the World Health Organization Quality of Life Scale, were applied to the patients in the experimental and control groups. will participate in the research, will be asked, and will be filled in face to face by the responsible researcher. After the progressive relaxation exercise training is given to the experimental group patients, the voice recording containing the commands for the application of the progressive relaxation exercise will be sent to the phone of the patient and/or their relatives. Patients in the experimental group spent an average of 25-30 minutes each day for four weeks. Ongoing exercises will be conducted and followed up. At the end of the fourth week, "Beck Anxiety Scale and World Health Organization Quality of Life Scale" will be applied.

Other: progressive relaxation exercise

Diabetic patients not applied progressive relaxation exercise

NO INTERVENTION

After explaining the purpose of the study and obtaining their verbal and written consents, a questionnaire form including the Beck Anxiety Scale and the World Health Organization Quality of Life Scale, in which the socio-demographic characteristics of the experimental and control group patients who will participate in the research, are asked, will be filled in face to face by the principal researcher.Then, a voice recording containing the commands for the application of the progressive relaxation exercise will be sent to the phone of the volunteer patients in this group and/or their relatives, and they will be informed about how to apply it.

Interventions

Step 1: Take a comfortable position (sitting or lying down) and wear comfortable, non-tightening clothes. Step 2: Try to relax with eyes closed, without focusing on thoughts, by focusing on your own body muscles. Step 3: Right and left, respectively, hands, arms (triceps muscle), chest, abdomen, hips, legs (thigh muscles), feet and toes, neck, shoulder (scapula muscles) and muscle groups on the face (around the eyes, chin) and eyebrow muscles) by concentrating on contracting and relaxing these muscles. Step 4: Focusing on the muscle groups of the whole body, contracting and relaxing. Step 5: Opening the eyes slowly, trying to feel the feeling of comfort in the body (Turkish Psychologists Association Progressive Relaxation Exercises).

Diabetic patients undergoing progressive relaxation exercise

Eligibility Criteria

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

You may qualify if:

  • Diabetic patients who will be treated in the Internal Medicine Service who want to participate in the study voluntarily.
  • Patients over the age of 18

You may not qualify if:

  • Patients who do not want to participate in the study.
  • Patients who are unable to perform the progressive relaxation exercise (amputation, etc.).
  • Pregnant or breastfeeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Üniversitesi

Erzurum, 25030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDiabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Mental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Central Study Contacts

Gazi Baran CAMCİ

CONTACT

Esin Kavuran

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The experimental group consisted of 52 people (the group in which progressive movements exercises were applied) and the control group consisted of 52 people, a total of 104 people. Patients who meet the sample selection criteria are randomized using the Random Integer Generator method from the Random.org organelle Numbers sub-title. In the randomization, the 1-digit experiment will continue to represent the 2-digit control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Department of Nursing Principles

Study Record Dates

First Submitted

July 5, 2023

First Posted

October 12, 2023

Study Start

October 10, 2023

Primary Completion

December 31, 2024

Study Completion

January 1, 2025

Last Updated

August 29, 2024

Record last verified: 2024-08

Locations