NCT05997394

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

August 10, 2023

Last Update Submit

July 12, 2024

Conditions

Keywords

DYSPNEASPIRITUAL GOODNESSANXIETY

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    1 month

Study Arms (2)

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.

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.

Interventions

Participants who are in the experimental group will be given a prayer audience.

Experimental Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zile Devlet Hastanesi

Tokat Province, 60000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspneaAnxiety Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsMental Disorders

Study Officials

  • Gülden Kaygusuz Gülden Kaygusuz

    Tokat Zile Devlet Hatanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The experimental and control groups will be determined by randomization method by a person other than the researcher. Participants will not know which group they are in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It is a semi-experimental type of study. It consists of two groups: experiment and control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

January 10, 2024

Primary Completion

March 26, 2024

Study Completion

May 4, 2024

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

It is not intended to share the data of individual participants.

Locations