NCT06441838

Brief Summary

In addition to physical symptoms, mental, social and economic problems may also occur in patients receiving hemodialysis treatment. The most prominent among these problems are psychological problems. It is known that depression and anxiety levels are high in hemodialysis patients.Non-pharmacological methods reduce the patient's pain and anxiety by creating a feeling of comfort and control in the patient. Relaxation techniques such as hypnosis, yoga and music are among these. The main purpose of these methods is to draw the attention of the individual in another direction. Praying is also one of the non-drug methods, and the number of studies on this subject is very limited, and there are studies where it has been determined that praying and praying reduces the anxiety levels of patients.Purpose: To examine the effect of listening to Surah Inshirah on depression, anxiety, stress and mental well-being of hemodialysis patients during treatment. Method: The population of the research will consist of hemodialysis patients who are treated at Mardin Training and Research Hospital, meet the inclusion criteria and volunteer to participate in the research. The study group of 60 people who will participate in the research will be divided into two equal groups according to the table of random numbers obtained from the computer-based Research Randomizer program. Experimental group patients; A patient descriptive characteristics form will be applied, and the pre-test depression, anxiety, stress and mental well-being scale will be applied. Then, Surah Inshirah will be listened to and the final test, the depression, anxiety, stress and mental well-being scale, will be applied. Control group patients; A patient descriptive characteristics form will be applied, and the depression, anxiety, stress and mental well-being scale will be applied. The final test will be applied to the depression, anxiety, stress and mental well-being scale without any intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

April 20, 2024

Last Update Submit

June 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • patient information form

    This form, created by the researcher with the support of the relevant literature, consists of 8 questions that question the patients' education level, age, gender, profession, marital status, income level, with whom they live, and duration of illness.

    Baseline (It will be applied to patients before hemodialysis)

Secondary Outcomes (1)

  • depression anxiety stress scale

    Baseline (It will be applied to patients before hemodialysis)

Other Outcomes (1)

  • mental well-being scale

    Baseline (It will be applied to patients before hemodialysis)

Study Arms (2)

Listening to Surah Inshirah

EXPERIMENTAL

Experimental group patients; A patient descriptive characteristics form will be administered, and the pre-test Depression, Stress, Anxiety Scale and Warwick-Edinburgh Mental Well-Being Scale will be administered. Then, Surah Inshirah will be listened to and the final test, Depression, Stress, Anxiety Scale and Warwick-Edinburgh Mental Well-Being Scale will be administered.

Behavioral: Surah Inshirah

control group

NO INTERVENTION

intervention group patients; Patient descriptive characteristics form, Depression, Stress, Anxiety Scale and Warwick-Edinburgh Mental Well-Being Scale will be administered. Then, the Depression, Stress, Anxiety Scale and Warwick-Edinburgh Mental Well-Being Scale will be administered 1 month later without any intervention.

Interventions

Surah InshirahBEHAVIORAL

The effects of Surah Al-Inshirah on patients' depression, anxiety, stress and mental well-being will be evaluated during hemodialysis in the experimental group.

Listening to Surah Inshirah

Eligibility Criteria

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

You may qualify if:

  • Patients who can be contacted,Patients aged 18 and over were included in the study.

You may not qualify if:

  • Patients aged 18 and over were included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ömer TANRIVERDİ

Mardin, Turkey (Türkiye)

Location

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
Asistant Professor

Study Record Dates

First Submitted

April 20, 2024

First Posted

June 4, 2024

Study Start

February 20, 2024

Primary Completion

March 23, 2024

Study Completion

March 23, 2024

Last Updated

June 4, 2024

Record last verified: 2024-05

Locations