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The effect of emotional self- disclosure on disease activity, health status and sexual function in women with rheumatoid arthritis in comparison with control group

Protocol summary

Study aim
Determining the effect of emotional self disclosure on disease activity, health status and sexual function in women with rheumatoid arthritis
Design
A clinical trial with a control group, randomized, on 72 patients, the selection of sample subjects in a continuous method and the allocation of the samples to the test group (A) or control (B) will be done using the double block method.
Settings and conduct
The research will be conducted in a selected rheumatology clinic in Tehran. After receiving oral and written explanations related to the intervention, the participants of the test group will reveal their emotions in writing in the notebook, and the control group will receive only routine care.
Participants/Inclusion and exclusion criteria
Entry condition: age 18-45, at least 6 months have passed since the diagnosis, able to read and write in Persian, living with a spouse, having sexual activity, husband being monogamous, living in Tehran; Non-entry criteria: chronic disease other than rheumatoid arthritis in the research units, pregnancy or breastfeeding and less than 6 months have passed since the last delivery, the occurrence of a stressful event from 3 months before the intervention according to the patient's statement, suffering from major medical diseases affecting sexual function, sexual disorders being treated in woman or husband.
Intervention groups
Test: The participants will reveal their feelings in writing at home and preferably in a private room, once a day and 4 times a week for 4 weeks, and in the notebook they will reveal their emotions in written form. control: After the pre-test they will receive only routine care.
Main outcome variables
Disease activity; Health status; Sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110629006917N6
Registration date: 2022-08-19, 1401/05/28
Registration timing: registered_while_recruiting

Last update: 2022-08-19, 1401/05/28
Update count: 0
Registration date
2022-08-19, 1401/05/28
Registrant information
Name
Leila Amini
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 6574
Email address
l-amini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-30, 1401/05/08
Expected recruitment end date
2023-03-28, 1402/01/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of emotional self- disclosure on disease activity, health status and sexual function in women with rheumatoid arthritis in comparison with control group
Public title
The effect of emotional self- disclosure on disease activity, health status and sexual function in women with rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 years At least 6 months have passed since the diagnosis of the disease Able to read and write in Farsi Living with a spouse at the time of the study Having sexual activity at least once in the last 4 weeks Monogamous husband Living in Tehran
Exclusion criteria:
Suffering from another chronic disease other than Rheumatoid arthritis in research units Current pregnancy or breastfeeding and less than 6 months have passed since the last delivery According to the patient, the occurrence of a stressful incident 3 months before the intervention Suffering from major medical diseases affecting sexual relations (Diabetes, history of psychiatric disorders such as severe Depression, Psychosis, Bipolar disorder, substance abuse) according to the patient' statement and the contents of his file Taking drugs affecting sexual performance Sexual disorders under treatment in women or husbands (desire phase disorder, arousal phase disorder, orgasm disorder, sexual pain disorders)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of sample people will be done in a continuous method and the allocation of the samples to the test group (a) or control (b) will be done by the double block method. In this way, a person outside the research team will write different states of two groups (4 states in total: 1-A, B, 2-B, A, 3-A, A, and 4-B, B) on 4 note cards and will put each one in a closed envelope so that the researcher doesn't know the order of placement of people in two groups before opening the envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Iran Nursing and Midwifery School, Rashid Yasemi Ave., Vali-e-Asr Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2022-06-20, 1401/03/30
Ethics committee reference number
IR.IUMS.REC.1401.272

Health conditions studied

1

Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor

Primary outcomes

1

Description
Disease activity
Timepoint
In each of the two test and control groups before the start of the study and 8 weeks after the intervention
Method of measurement
In both groups, it will be measured by a rheumatology specialist using the 28-DAS tool.

2

Description
Health status
Timepoint
The measurement of this variable will be done before the start of the study, immediately and 8 weeks after the end of the intervention.
Method of measurement
Completing the health status questionnaire (AIMS2-SF) by the participants

3

Description
Sexual function
Timepoint
The measurement of this variable in all 6 areas will be done before the start of the study, immediately and 8 weeks after the end of the intervention.
Method of measurement
Completion of the Female Sexual Function Index (FSFI) questionnaire by the participants

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First, the participants will complete questionnaires including demographic characteristic, clinical status of the disease, FSFI (Female Sexual Function Index) and AIMS2-SF (health status questionnaire). Also before the study, the disease activity of both groups will be measured using the DAS-28 tool by a rheumatologist. Then participants will receive a notebook to writing their feelings freely. In this study, the researcher will give complete oral explanations about the intervention implementation to participants in intervention group. Also, a written guide of the intervention implementation method will be given to them. The intervention group participants will express their feelings freely and voluntarily at home and preferably in a private room, once a day and 4 times a week for 4 weeks. Free writing of emotions will be regardless of spelling and compositional points. During the study period, the writing process of the patients will be followed up by the researcher at the end of each week via phone call. After the completion of the intervention, the study questionnaire will be sent via WhatSapp and email and participants will completed them again.
Category
Rehabilitation

2

Description
Control group: First, the participants will complete questionnaires of demographic information and clinical status of the disease, FSFI (Female Sexual Function Index) and AIMS2-SF (health status questionnaire) before studying the disease activity of both group using the DAS-28 will be measured. The control group will receive only routine care after the pre-test.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology subspecialty clinic in Tehran
Full name of responsible person
Dr. Anousheh Haghighi
Street address
Unit 6, Second floor, Kouh Noor doctors building, It has not reach Fajr Street, Motahari
City
Tehran
Province
Tehran
Postal code
1588645413
Phone
+98 21 8881 0475
Email
Haghighi.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amini
Street address
Iran University of Medical Sciences, Hemmat Highway, Next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Elnaz Ashrafpour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasemi Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Email
elnazashrafpour@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amini
Position
Assistant professor of reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rashid Yasemi Street, Vali-e-asr Ave
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
Amini.l@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elnaz Ashrafpour
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasemi Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Email
elnazashrafpour@gmail.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
No more 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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