COPDCOPDNCT05997394
The Effect of Prayer on Dyspnea Severity, Anxiety and Spiritual Well-Being in Individuals With COPD
A study testing A prayer concert will be held for the participants. in people with COPD, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted in order to examine the effect of prayer to individuals with COPD on the severity of dyspnea, anxiety and spiritual well-being experienced by patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- A prayer concert will be held for the participants.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 4 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 90 individuals (45 experiments, 45 controls) who can be contacted, who have agreed to participate in the study
- who are literate, can speak Turkish
- who have not participated in a similar application of this study before
- who have agreed to participate in the study after being informed about the research
- are 18 years old and over, with a COPD diagnosis will be taken
Who cannot join
- Individuals with mental and hearing problems, who have lost a family member and someone close to them in the last year
- who are using tranquilizers/antidepressants
- who have experienced a traumatic situation such as divorce will be excluded from the sample.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted in order to examine the effect of prayer to individuals with COPD on the severity of dyspnea, anxiety and spiritual well-being experienced by patients.
Read the detailed description
This study will be conducted on people with COPD. People with COPD disease will be divided into two groups. The experimental group will be given a prayer lesson for a month. Prayer listening will not be performed to the control group. At the end of one month, the severity of dyspnea, anxiety and spiritual well-being levels of people in both groups will be re-evaluated.
- Conditions
- COPD
- Being tested
- A prayer concert will be held for the participants.
- Keywords
- DYSPNEA, SPIRITUAL GOODNESS, ANXIETY
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A prayer concert will be held for the participants.Other
Participants who are in the experimental group will be given a prayer audience.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this group will be given a prayer concert for a month. At the end of one month, the severity of dyspnea, anxiety and spiritual well-being levels experienced by the participants will be re-checked. Receives: Other: A prayer concert will be held for the participants. |
| Control Group | No intervention | There will be no prayer audience for participants in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
dyspnea 12 scale
as a result of 1-month prayer listening, the severity of dyspnea of the participants in the experimental group decreased. A minimum of 0 and a maximum of 36 points are taken from the scale. The increase in scores indicates that the frequency of dyspnea of patients has increased.
Measured: 1 month
Beck anxiety scale
as a result of listening to prayer for 1 month, the anxiety severity of the participants in the experimental group decreased. A minimum of 0 and a maximum of 63 points are taken from the scale. The increase in scores indicates that the frequency of anxiety of patients has increased.
Measured: 1 month
Spiritual Well-Being Scale
as a result of listening to prayer for 1 month, the spiritual well-being levels of the participants in the experimental group increased. A minimum of 0 and a maximum of 48 points are taken from the scale. An increase in scores indicates an increase in the spiritual well-being of patients.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start10 Jan 2024
- Primary completion26 Mar 2024
- Study completion4 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a semi-experimental type of study. It consists of two groups: experiment and control.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülden Kaygusuz, Cumhuriyet University
- Investigators
- Gülden Kaygusuz Gülden Kaygusuz, Principal investigator, Tokat Zile Devlet Hatanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997394
- Sponsor's protocol ID
- SCU-SBF-GK-01
- Acronym
- COPD
- Status last verified
- Jul 2024
- First submitted
- 10 Aug 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not intended to share the data of individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prayer on Dyspnea Severity, Anxiety and Spiritual Well-Being in Individuals With COPD
- ClinicalTrials.gov ID
- NCT05997394
- Acronym / sponsor ID
- COPD / SCU-SBF-GK-01
- Conditions
- COPD
- Keywords
- DYSPNEA, SPIRITUAL GOODNESS, ANXIETY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 4 May 2024 (actual)
- First posted
- 18 Aug 2023 (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.
This study will be conducted in order to examine the effect of prayer to individuals with COPD on the severity of dyspnea, anxiety and spiritual well-being experienced by patients.
Detailed description
This study will be conducted on people with COPD. People with COPD disease will be divided into two groups. The experimental group will be given a prayer lesson for a month. Prayer listening will not be performed to the control group. At the end of one month, the severity of dyspnea, anxiety and spiritual well-being levels of people in both groups will be re-evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- It is a semi-experimental type of study. It consists of two groups: experiment and control.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: A prayer concert will be held for the participants.Participants in this group will be given a prayer concert for a month. At the end of one month, the severity of dyspnea, anxiety and spiritual well-being levels experienced by the participants will be re-checked. |
| Control Group | No intervention | –There will be no prayer audience for participants in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 90 individuals (45 experiments, 45 controls) who can be contacted, who have agreed to participate in the study
- who are literate, can speak Turkish
- who have not participated in a similar application of this study before
- who have agreed to participate in the study after being informed about the research
- are 18 years old and over, with a COPD diagnosis will be taken
Key exclusion criteria (3 listed)
- Individuals with mental and hearing problems, who have lost a family member and someone close to them in the last year
- who are using tranquilizers/antidepressants
- who have experienced a traumatic situation such as divorce will be excluded from the sample.
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 |
|---|---|---|
| A prayer concert will be held for the participants.Participants who are in the experimental group will be given a prayer audience. | Other | Experimental Group |
Primary outcome
dyspnea 12 scale
Time frame: 1 month
as a result of 1-month prayer listening, the severity of dyspnea of the participants in the experimental group decreased. A minimum of 0 and a maximum of 36 points are taken from the scale. The increase in scores indicates that the frequency of dyspnea of patients has increased.
Beck anxiety scale
Time frame: 1 month
as a result of listening to prayer for 1 month, the anxiety severity of the participants in the experimental group decreased. A minimum of 0 and a maximum of 63 points are taken from the scale. The increase in scores indicates that the frequency of anxiety of patients has increased.
Spiritual Well-Being Scale
Time frame: 1 month
as a result of listening to prayer for 1 month, the spiritual well-being levels of the participants in the experimental group increased. A minimum of 0 and a maximum of 48 points are taken from the scale. An increase in scores indicates an increase in the spiritual well-being of patients.
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 16 Jul 2024.
- Individual participant dataSharing planned: No. It is not intended to share the data of individual participants.
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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.
Gülden Kaygusuz Gülden Kaygusuz principal investigator
Tokat Zile Devlet Hatanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A prayer concert will be held for the participants. in people with COPD, run by Cumhuriyet 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 5 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 16 Jul 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?
dyspnea 12 scale (time frame: 1 month). The study lists 3 primary outcomes in all. 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 16 Jul 2024.