Hemodialysis PatientsNCT06441838
The Effect of Listening to Surah Inshirah on Mental Health in Hemodialysis Patients.
A study testing Surah Inshirah in people with Hemodialysis Patients, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Surah Inshirah
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2024to 23 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who can be contacted,Patients aged 18 and over were included in the study.
Who cannot join
- Patients aged 18 and over were included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Listening to the Inshirah Surah on Depression, Anxiety, Stress and Mental Well-Being in Hemodialysis Patients.
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.
Read more
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.
- Conditions
- Hemodialysis Patients
- Being tested
- Surah Inshirah
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surah InshirahBehavioural
The effects of Surah Al-Inshirah on patients' depression, anxiety, stress and mental well-being will be evaluated during hemodialysis in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (It will be applied to patients before hemodialysis)
Secondary outcomes (1)
depression anxiety stress scale
It consists of 7 depression, 7 anxiety and 7 stress questions.
Measured: Baseline (It will be applied to patients before hemodialysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start20 Feb 2024
- Primary completion23 Mar 2024
- Study completion23 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Tanriverdi, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441838
- Sponsor's protocol ID
- Mardin Artuklu Üniversitesi
- Status last verified
- May 2024
- First submitted
- 20 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to the Inshirah Surah on Depression, Anxiety, Stress and Mental Well-Being in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT06441838
- Acronym / sponsor ID
- Mardin Artuklu Üniversitesi
- Conditions
- Hemodialysis Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 23 Mar 2024 (actual)
- Study completion
- 23 Mar 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Listening to Surah Inshirah | Experimental | Behavioral: Surah InshirahExperimental 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who can be contacted,Patients aged 18 and over were included in the study.
Key exclusion criteria (1 listed)
- Patients aged 18 and over were included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surah InshirahThe effects of Surah Al-Inshirah on patients' depression, anxiety, stress and mental well-being will be evaluated during hemodialysis in the experimental group. | Behavioural | Listening to Surah Inshirah |
Primary outcome
patient information form
Time frame: Baseline (It will be applied to patients before hemodialysis)
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.
1 secondary outcome
depression anxiety stress scale
Time frame: Baseline (It will be applied to patients before hemodialysis)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surah Inshirah in people with Hemodialysis Patients, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient information form (time frame: Baseline (It will be applied to patients before hemodialysis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.