Protocol summary

Study aim
Determination of the effect of cardiac rehabilitation through telenursing on sexual satisfaction and fatigue in patients with different types of heart rhythm management devices and their spouses
Design
A randomized controlled clinical trial, with parallel groups and single blind
Settings and conduct
At arrhythmias clinics affiliated to Shiraz University of Medical Sciences Training and counseling (about fatigue and sexual satisfaction) during in person and non in-person session. Single blind: Outcome evaluator، Data analyzer
Participants/Inclusion and exclusion criteria
Married and sexually active patient (only one spouse) aged 18 to 70 years old and has one of a different types of heart rhythm management devices and has been implanted at least three months.
Intervention groups
Intervention group (patient plus his / her spouse) during an 8-week period including 8 sessions of cardiac rehabilitation: 2 in-person sessions including training and counseling on fatigue and sexual satisfaction for two weeks (one session per week) and after in-person sessions starting with the third week of the intervention, 6 non-face-to-face sessions will be followed by 6-week telephone follow_ups (one call per week by the nurse). Also, educational-motivational text messages will be sent three times a week from the beginning of the rehabilitation period. Patients will perform exercise sessions at home according to the cardiac electrophysiology practitioner and based on the instruction booklet we will provide. In the control group, there is no intervention, and patients will receive only routine training and routine care.
Main outcome variables
Sexual satisfaction and fatigue in patients with different types of heart rhythm management devices and their spouses

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200302046662N1
Registration date: 2020-03-07, 1398/12/17
Registration timing: prospective

Last update: 2020-03-07, 1398/12/17
Update count: 0
Registration date
2020-03-07, 1398/12/17
Registrant information
Name
Fatemeh Sabetghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3837 0559
Email address
f_sabetghadam@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of cardiac rehabilitation via telenursing on sexual satisfaction and fatigue of patients with different types of heart rhythm management devices and their spouses at arrhythmias clinics affiliated to Shiraz University of Medical Sciences
Public title
Investigation of the effect of cardiac rehabilitation on patients with different types of heart rhythm management devices and their spouses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Has one of a different types of heart rhythm management devices and has been implanted for at least three months Be married Only have one spouse 18 to 70 years old Not diagnosed mental illness and acute cognitive disorders Not having severe orthopedic, neurological, visual and hearing problems Ability to understand and speak and read and write Persian language Phone access (fixed and mobile) after discharge Have sexual activity
Exclusion criteria:
Incidence of unstable angina Uncontrolled blood pressure, resting systole greater than 180 mmHg or diastolic resting time greater than 110 mmHg Severe neurological, orthopedic and musculoskeletal problems that occur during the study and prevent them from being active The patient's unwillingness to continue attending the study Not attending one of the pre- or post-test sessions Not attending one of the in person sessions
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Using the stratified random sampling method, here are the classes of Cardiac resynchronization therapy, implantable cardiac defibrillator and pacemaker to fit each class, 14 patients with Cardiac resynchronization therapy, 22 patients with implantable cardiac defibrillator and 32 patients with Pacemakers will first be selected as available sampling in the aforementioned classes, and then random allocation using Random allocation Software to generate block randomization lists of each block size 2 or 4 2 blocks of 7, floor implantable cardioverter defibrillator The size of 2 blocks of 11 blocks and the pacemaker class 4 blocks of 8 blocks will be divided into control and patient groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to single blind , questionnaires will be collected by the first researcher and assigned to intervention and control groups by the second researcher, so the outcome assessor will be kept blind. Also, the person analyzing the data will not be aware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
The present study will be conducted on couples and patients' spouses will be included.Therefore, the intervention group (34 patients plus 34 spouses) and the control group (34 patients plus 34 spouses) will total 68 couples (136 persons).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Fatemeh(P.B.U.H)School of Nursing and Midwifery, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Approval date
2020-01-15, 1398/10/25
Ethics committee reference number
IR.SUMS.REC.1398.1195

Health conditions studied

1

Description of health condition studied
Patients with different types of heart rhythm management devices
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Spouses of patients with different types of heart rhythm management devices
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Level of sexual satisfaction in Hudson Index of Sexual Satisfaction questionnaire
Timepoint
At baseline (before intervention) and 2 months after intervention
Method of measurement
Hudson Index of Sexual Satisfaction

2

Description
Fatigue score on the Fatigue Severity Scale Questionnaire
Timepoint
At baseline (before intervention) and 2 months after intervention
Method of measurement
Fatigue Severity Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group (patient plus his / her spouse) during an 8-week period including 8 sessions of cardiac rehabilitation: 2 in-person sessions including training and counseling on fatigue and sexual satisfaction for two weeks (one session per week) and after in-person sessions starting with the third week of the intervention, 6 non-face-to-face sessions will be followed by 6-week telephone follow_ups (one call per week by the nurse). Also, educational-motivational text messages will be sent three times a week from the beginning of the rehabilitation period. Patients will perform exercise sessions at home according to the cardiac electrophysiology practitioner and based on the instruction booklet we will provide.
Category
Rehabilitation

2

Description
Control group: There is no intervention, and patients will receive only routine training and routine care.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arrhythmia clinic of Alzahra Heart Hospital
Full name of responsible person
Fatemeh Sabetghadam
Street address
Sibouyeh Boulevard, Astana Three Way, Alzahra Heart Charity Hospital
City
Shiraz
Province
Fars
Postal code
۵۴۹۳۷-۷۱۶۴۹
Phone
+98 71 3739 8811
Fax
Email
hfcmanager@sums.ac.ir

2

Recruitment center
Name of recruitment center
Arrhythmia clinic of Shahid Faghihi Hospital
Full name of responsible person
Fatemeh Sabetghadam
Street address
Karim Khan Zand Boulevard - Next to Medical School
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Fax
Email
faghihihsp@sums.ac.ir

3

Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Fatemeh Sabetghadam
Street address
Namazi Square, next to Namazi Hospital
City
Shiraz
Province
Fars
Postal code
714737-71348
Phone
+98 71 3212 7001
Email
motahari@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Younes Ghasemi
Street address
Central building of Shiraz University of Medical Sciences Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2713
Fax
+98 71 3230 8200
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Mahnaz Rakhshan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatemeh (P.B.U.H) School of Nursing and Midwifery, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
0098 7136474254-8
Email
rakhshanm@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahnaz Rakhshan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatemeh (P.B.U.H) School of Nursing and Midwifery, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
0098 7136474254-8
Email
rakhshanm@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Sabetghadam
Position
Master of Adult Critical Care Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Fatemeh(P.B.U.H) School of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3837 0559
Fax
Email
f_sabetghadam@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
- Obtaining an official letter from the Fatemeh School of Nursing and Midwifery of Shiraz and obtaining permission from the authorities of Shiraz University of Medical Sciences. - Obtain written consent from the sample to participate in the study. - Ensure that the research units are confident of the information received. - Freely and voluntarily participate in the research and consider the right to opt out of research. - Creating a private environment for interviewing the patient and completing the questionnaire. - Providing research results if desired by the training center where the researcher has sampled.
When the data will become available and for how long
After completing the study and publishing the results
To whom data/document is available
Private and public hospitals Cardiac rehabilitation centers The training center where the researcher has sampled.
Under which criteria data/document could be used
- Obtain the permission of the respected authorities at the College, University and Hospital. - Confidentiality of participants' information
From where data/document is obtainable
Shiraz. Zand Street, Library of Shiraz School of Nursing and Midwifery. Phone: 0098 7136474254
What processes are involved for a request to access data/document
Requests for results are sent to the library of Shiraz School of Nursing and Midwifery. They will be provided with the coordination.
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