Sequelae of; Complications Surgical and Medical CareNCT06326541
The Effect of Listening to the Holy Quran on Vital Signs in Coma Patients
A study testing music therapy in people with Sequelae of; Complications Surgical and Medical Care, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of the Holy Quran listened to to coma patients on their vital signs. Does listening to the Holy Quran have a positive effect on the life values of coma patients? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sequelae of; Complications Surgical and Medical Care
- What is being tested?
- music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 30 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being over 18 years of age
- Being a surgical intensive care patient
- Having a Glasgow coma score of 8 points or less
Who cannot join
- The patient must be under 18 years of age
- Have a Glaskow coma score above 8 points
- Be out of coma during the time the research continues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Listening to the Holy Quran on Life Findings in Coma Patients Hospitalized in Surgical Intensive Care Unit
The aim of this study is to examine the effect of the Holy Quran listened to to coma patients on their vital signs.
Does listening to the Holy Quran have a positive effect on the life values of coma patients?
Read the detailed description
This study aims to examine the effect of listening to the Holy Quran on vital signs (fever, pulse, respiration, systolic-diastolic blood pressure, saturation) in surgical intensive care unit patients. The unique value of this study, unlike other studies, is to examine the positive changes in patients' vital signs by listening to the Holy Quran (Surah Rahman) instead of classical music.
- Being tested
- music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyBehavioural
Listening to the Holy Quran.
| Study group | Role | What they receive |
|---|---|---|
| music therapy | Experimental | music therapy Receives: Behavioral: music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure- (mmHg)
Vital Signs Values of Patients Before and After Application
Measured: 30 minutes
diastolic blood pressure- (mmHg)
Vital Signs Values of Patients Before and After Application
Measured: 30 minutes
pulse (number of beats/min)
Vital Signs Values of Patients Before and After Application
Measured: 30 minutes
body temperature (degrees Celsius)
Vital Signs Values of Patients Before and After Application
Measured: 30 minutes
saturation (%-oxygen saturation)
Vital Signs Values of Patients Before and After Application
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start5 Jan 2023
- Primary completion10 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sequelae of; Complications Surgical and Medical CareStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- single group pretest-posttest
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serafettin Okutan, Bitlis Eren University
- Investigators
- Şerafettin OKUTAN, Dr., Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326541
- Sponsor's protocol ID
- okutan
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yorke J, Wallis M, McLean B. Patients' perceptions of pain management after cardiac surgery in an Australian critical care unit. Heart Lung. 2004 Jan-Feb;33(1):33-41. doi: 10.1016/j.hrtlng.2003.09.002.
PubMed 14983137
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to the Holy Quran on Life Findings in Coma Patients Hospitalized in Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06326541
- Acronym / sponsor ID
- okutan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 22 Mar 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.
The aim of this study is to examine the effect of the Holy Quran listened to to coma patients on their vital signs.
Does listening to the Holy Quran have a positive effect on the life values of coma patients?
Detailed description
This study aims to examine the effect of listening to the Holy Quran on vital signs (fever, pulse, respiration, systolic-diastolic blood pressure, saturation) in surgical intensive care unit patients. The unique value of this study, unlike other studies, is to examine the positive changes in patients' vital signs by listening to the Holy Quran (Surah Rahman) instead of classical music.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group pretest-posttest
| Arm | Type | Receives |
|---|---|---|
| music therapy | Experimental | Behavioral: music therapymusic therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being over 18 years of age
- Being a surgical intensive care patient
- Having a Glasgow coma score of 8 points or less
Key exclusion criteria (3 listed)
- The patient must be under 18 years of age
- Have a Glaskow coma score above 8 points
- Be out of coma during the time the research continues
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 |
|---|---|---|
| music therapyListening to the Holy Quran. | Behavioural | music therapy |
Primary outcome
systolic blood pressure- (mmHg)
Time frame: 30 minutes
Vital Signs Values of Patients Before and After Application
diastolic blood pressure- (mmHg)
Time frame: 30 minutes
Vital Signs Values of Patients Before and After Application
pulse (number of beats/min)
Time frame: 30 minutes
Vital Signs Values of Patients Before and After Application
body temperature (degrees Celsius)
Time frame: 30 minutes
Vital Signs Values of Patients Before and After Application
saturation (%-oxygen saturation)
Time frame: 30 minutes
Vital Signs Values of Patients Before and After Application
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 22 Mar 2024.
- Results publication: PubMed 14983137Yorke J, Wallis M, McLean B. Patients' perceptions of pain management after cardiac surgery in an Australian critical care unit. Heart Lung. 2004 Jan-Feb;33(1):33-41. doi: 10.1016/j.hrtlng.2003.09.002.
- Individual participant dataSharing planned: No
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.
Şerafettin OKUTAN, Dr. principal investigator
Bitlis Eren University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy in people with Sequelae of; Complications Surgical and Medical Care, run by Bitlis Eren 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 3 inclusion and 3 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 22 Mar 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?
systolic blood pressure- (mmHg) (time frame: 30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326541, which also lists 1 linked publication.
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 22 Mar 2024.