Protocol summary

Study aim
Investigating the effect of pulmonary rehabilitation on sexual satisfaction and sexual self-efficacy of patients with chronic obstructive pulmonary disease
Design
This is a randomized clinical trial with a parallel design, non-blinded, and a control group. The research population will include all chronic obstructive pulmonary disease patients referred to Dasht Azadegan Clinic in Isfahan. A total of 40 eligible people will be selected conveniently. A simple random method is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted in Dasht Azadegan Clinic in Isfahan City, is not blinded. Both groups will first complete sexual satisfaction and sexual self-efficacy questionnaires. After implementing the protocol for the intervention group, the questionnaires will be provided to both groups again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; A definitive diagnosis of COPD by a doctor; A physically and sexually healthy wife Exclusion criteria: History of suffering from sexual problems and diseases; Smoking history; History of heart disease
Intervention groups
The intervention group will undergo pulmonary rehabilitation training for 8 weeks (one hour per session). The control group will not receive any intervention.
Main outcome variables
Sexual satisfaction, sexual self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130812014333N205
Registration date: 2023-07-19, 1402/04/28
Registration timing: registered_while_recruiting

Last update: 2023-07-19, 1402/04/28
Update count: 0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-15, 1402/04/24
Expected recruitment end date
2023-08-20, 1402/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of pulmonary rehabilitation on sexual satisfaction and sexual self-efficacy of patients with chronic obstructive pulmonary disease
Public title
Investigating the effect of pulmonary rehabilitation on sexual satisfaction and sexual self-efficacy of patients with chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent A definitive diagnosis of COPD by a doctor A physically and sexually healthy wife
Exclusion criteria:
History of suffering from sexual problems and diseases Smoking history History of heart disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple random method, after identifying eligible patients, they will be randomly assigned a three-digit dedicated code. The last digit on the right determines the patient group. If this number is 0, 1, 2, 3, 4, it will be assigned in the intervention group, and if this number is 5, 6, 7, 8, 9, it will be assigned in the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2022-06-25, 1401/04/04
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.131

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Sexual satisfaction
Timepoint
The beginning of the study and the end of the study (one month later)
Method of measurement
Sexual satisfaction questionnaire

2

Description
sexual self-efficacy
Timepoint
The beginning of the study and the end of the study (one month later)
Method of measurement
Sexual self-efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will undergo pulmonary rehabilitation training for 8 weeks (one hour per session).
Category
Behavior

2

Description
The control group will not receive any intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dasht Azadegan Clinic
Full name of responsible person
Mahdi Jalali
Street address
Azadegan Dental Clinic, 12th Alley, Freiburg Str, Mordavij Streeteet,
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3670 0792
Email
mahdi.jalali@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Majid Meshkini
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Khorasgan branch
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Mahdi Jalali
Position
Islamic Azad University, Khorasgan branch
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahahn
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
mahdi.jalali@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Mahdi Jalali
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
mahdi.jalali@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Mahdi Jalali
Position
Islamic Azad University, Khorasgan branch
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
mahdi.jalali@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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