Protocol summary

Study aim
Determining the effect of counseling with stress management approach and relationship enrichment approach on sexual satisfaction and marital satisfaction of working women with high job stress
Design
This quasi-experimental study was performed on 75 nurses and midwives and participants randomly using the website www.random.org through block shifts based on work shifts (fixed or rotating) with Six or nine blocks and a 1: 1: 1 allocation ratio are assigned to three groups (stress management counseling, relationship enrichment counseling, and control group) and, for concealment, the type of intervention on paper and inside Opaque envelopes will be placed, numbered consecutively.
Settings and conduct
Teaching hospitals of Tabriz
Participants/Inclusion and exclusion criteria
1.Bachelor's degree in nursing and midwifery and above 2. Working women with at least one year of experience in the hospital 3. Having a spouse alive 4. Being sexually active and monogamous 5. Get a score greater than or equal to 100 of the job stress questionnaire 6. Not receiving personal counseling services during participation in treatment sessions No entry conditions 1. History of physical illnesses affecting sexual desire 2. Stressful variables such as disability or illness of a family member 3.Having a mental illness of yourself, your spouse or a family member 4. Occurrence of recent traumatic events and acute stress problem 5. Smoking, alcohol and drugs and other drugs that affect the body and mind 6. Taking drugs to reduce sexual desire 7. Menopause 8. Existence of sexual dysfunction in wife or spouse 8. Marital disputes affecting sexual relations
Intervention groups
The first group of counseling with a stress management approach and the second group of counseling with a relationship enrichment approach and a control group
Main outcome variables
Job stress, marital satisfaction and sexual satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110524006582N34
Registration date: 2020-11-12, 1399/08/22
Registration timing: registered_while_recruiting

Last update: 2020-11-12, 1399/08/22
Update count: 0
Registration date
2020-11-12, 1399/08/22
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-19, 1399/07/28
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with stress management approach and communication enhancement approach on sexual satisfaction and marital satisfaction of employed women with high occupational stress.
Public title
The effect of counseling with stress management approach and communication enhancement approach on sexual satisfaction and marital satisfaction of employed women with high occupational stress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Bachelor's degree in nursing and midwifery at the undergraduate level and above Working women with at least one year of hospital experience (including contract, plan and formal) Having a spouse alive Being sexually active and monogamous Get a score greater than or equal to 100 from the Job Stress Questionnaire Failure to receive individual counseling services while attending treatment sessions
Exclusion criteria:
Having a history of physical illnesses affecting sexual desire (having organ lesions, developing a chronic physical illness such as high blood pressure, diabetes) Stress variables such as disability or illness of a family member (cancer, retardation, etc.) Occurrence of recent traumatic events and acute stressful problems (death of child, father, etc.) Having her own mental illness, spouse or family member according to the patient Smoking, alcohol and drugs and other drugs that affect the body and mind Menopause Taking drugs to reduce libido (antidepressants: fluoxetine, sertraline, paroxetine. Antihistamines: chlorpheniramine, drugs that affect blood pressure: clonidine, captopril, benzodiazepines such as alprazolam (Xanax) and .......
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Participants who completed the pre-test questionnaires randomly using the website www.random.org and through block classification based on work shift (fixed shift or rotating shift) with blocks Six or nine and a 1: 1: 1 allocation ratio to three groups (one group receiving stress management counseling, one group receiving marital relationship enrichment counseling, and one control group). Blocking will be done by a person not involved in sampling and data analysis. To hide the allocation, the type of intervention will be written on paper and placed inside the numbered envelopes, numbered consecutively (Allocation Concealment). The envelopes will be opened in the order in which the participants enter the study and the type of intervention received by them will be determined. In order to prevent contamination, one person will be selected from each section, so that the first person who is eligible and willing to participate in the study will be selected from each section.
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 Research in Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences - Central Organization No. 2 - Vice Chancellor for Research
City
TABRIZ
Province
East Azarbaijan
Postal code
5165665931
Approval date
2019-11-25, 1398/09/04
Ethics committee reference number
IR.TBZMED.REC.1398.873

Health conditions studied

1

Description of health condition studied
Job stress, sexual satisfaction, marital satisfaction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Comparison of the mean score of sexual satisfaction, 2 weeks after the intervention in the control and intervention groups (2 groups receiving counseling) with controlling the effect of baseline score
Timepoint
Before the intervention and 2 weeks after the intervention in the control and intervention groups (2 groups receiving counseling) by controlling the effect of baseline score
Method of measurement
Larson Sexual Satisfaction Questionnaire

2

Description
Comparison of the mean score of marital satisfaction, 2 weeks after the intervention in the control and intervention groups (2 groups receiving counseling) controlling the effect of the base score
Timepoint
Before the intervention and 2 weeks after the intervention in the control and intervention groups (2 groups receiving counseling) controlling the effect of baseline score
Method of measurement
Enrich Marital Satisfaction Questionnaire

Secondary outcomes

1

Description
Comparison of mean job stress score 2 weeks after the intervention in control and intervention groups (2 groups receiving counseling) with controlling the effect of baseline score
Timepoint
Before the intervention and 2 weeks after the intervention in the control and intervention groups (2 groups receiving counseling) by controlling the effect of baseline score
Method of measurement
OSIPO Job Stress Questionnaire

Intervention groups

1

Description
Intervention group: Receiving counseling with a stress management approach. In this study, six counseling sessions will be held at intervals of one week for six consecutive weeks with groups of 4 to 6 people. Educational content of stress management approach: Introduction of stress management program, definition of stress and how it affects physical, mental and Social, sources of stress, providing an introduction to the importance and necessity of stress management skills training, addressing the differences between people in the face of stress and the cause of differences, thought-emotional communication, training and discussion about relaxation, stress and awareness, training and discussion of negative thoughts and behaviors, Steps for replacing rational thoughts, examining people's coping styles in stressful situations, introducing problem-oriented and emotion-oriented techniques as coping strategies with stress, objectifying the role of stress in life, cognitive reconstruction, problem solving, time management Positive Thinking, Self-Esteem, Self-Esteem and Dealing with Concerns, Diaphragm Relaxation and Breathing
Category
Behavior

2

Description
Intervention group: Recipient of counseling with relationship enrichment approach. In this study, six counseling sessions will be held at intervals of one week for six consecutive weeks with groups of 4 to 6 people. Speaking and negotiation skills as the first basic skill, self-expression skills training (second skill) and empathy skills (third skill). Enrichment training for couples and conflict resolution skills between them. Problem solving, reviewing problem-solving solutions, paying attention to strengths and weaknesses in dealing with problems. Train your change skills.
Category
Behavior

3

Description
Control group: Does not receive any intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Leily Kazemi
Street address
Tabriz - Azadi St. - Between the intersection of Shahid Montazeri and Hafez - Sina Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://sinahosp.tbzmed.ac.ir

2

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Leily Kazemi
Street address
Tabriz / Golgasht St., in front of the Central Organization of the University - Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/

3

Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Leily Kazemi
Street address
Tabriz - Daneshgah St. - Opposite to the University Research and Development Complex - Shahid Madani Cardiovascular Training and Research Center Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 3909
Fax
+98 41 3334 4021
Email
Madanihearthosp@tbzmed.ac.ir
Web page address
https://madanihosp.tbzmed.ac.ir/

4

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Leily Kazemi
Street address
South Army Street - Al-Zahra Educational and Medical Center, Baghshamal Crossroads
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
+98 41 3334 4280
Email
info@alzahrahosp.tbzmed.ac.ir
Web page address
https://alzahrahosp.tbzmed.ac.ir/

5

Recruitment center
Name of recruitment center
Taleghani Medical Research & Training Hospital
Full name of responsible person
Leily Kazemi
Street address
Tabriz / Railway Square / Taleghani Medical Training Center, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3442 4421
Fax
+98 41 3442 4882
Email
taleghani.hos@tbzmed.ac.ir
Web page address
https://taleghanihosp.tbzmed.ac.ir

6

Recruitment center
Name of recruitment center
children hospital
Full name of responsible person
Leily Kazemi
Street address
Tabriz / Sheshgalan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2250
Email
kodakanhospital@tbzmed.ac.ir
Web page address
https://childrenhospital.tbzmed.ac.ir

7

Recruitment center
Name of recruitment center
Shohada Medical Research & Training Hospital
Full name of responsible person
Leily Kazemi
Street address
Tabriz / Ail Goli Road / Golshahr St. 692 PO Box
City
Tabriz
Province
East Azarbaijan
Postal code
5138665692
Phone
+98 41 3389 3336
Email
shohadahospital@tbzmed.ac.ir

8

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Leily Kazemi
Street address
Tabriz / Shahid Bakeri Boulevard (el Goli)
City
Tabriz
Province
East Azarbaijan
Postal code
5138665692
Phone
+98 41 3380 4486
Email
info@prazi.tbzmed.ac.ir

9

Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Leily Kazemi
Street address
Tabriz, 5th of Mordad Square (formerly monajem Boulevard)
City
Tabriz
Province
East Azarbaijan
Postal code
5138665692
Phone
+98 41 3267 1770
Email
research-vice@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Golgasht Street, Research Office, No 2 Central Building, Tabriz University of Medical
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
samiei.moh@gmail.com
Grant name
En 20%Grant active researchers
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shariati Street, Faculty of Nursing Midwifery
City
Trizab
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
kamalifardm@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Master of sciences of midwifery, Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shariati Street, Faculty of Nursing Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
kamalifardm@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shariati Street, Tabriz Nursing Midwifery Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
kamalifard@tbzmed.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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