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Evaluation of the effectiveness of the educational intervention of emotional regulation strategies based on Gross model on emotion regulation strategies and psycho-social burden of women infected with human papillomavirus

Protocol summary

Study aim
Determining the effectiveness of the educational intervention of emotional regulation strategies based on Gross model on emotion regulation strategies and psycho-social burden of women infected with human papillomavirus referring to Kousar Urmia educational-medical center in Urmia-2022
Design
Single-group, single-blind, randomized controlled clinical trial of 100 patients. Sealed envelopes will be used for randomization.
Settings and conduct
Kousar Urmia educational-medical center The educational intervention will be carried out based on the educational protocol of grass-roots emotion regulation strategies. One-way blinding and not informing the participants about the randomization method
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a written informed consent, married, age range of 15-49 years, the husband knowing that his wife is infected with HPV disease, living in Urmia, having at least fifth grade education, definite diagnosis of HPV type in the last three months Exit criteria: pregnancy, unwillingness to cooperation, not participating in more than two sessions, divorce, not having sex during life, Occurrence of an acute psychological event
Intervention groups
For the control and intervention groups, after obtaining the written consent, the demographic information questionnaire, the HIP questionnaire and the Gross Emotion Regulation Scale will be completed. The educational intervention will be carried out based on the educational protocol of grass-roots emotion regulation strategies.
Main outcome variables
Reducing the psycho-social burden caused by HPV; Modifying or removing incompatible strategies and teaching adaptive emotion regulation strategies; preventing social isolation and avoiding emotional situations; Taking advantage of problem solving skills and interpersonal skills; Conducting cognitive reappraisal; Taking advantage of mindfulness methods

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221230056982N1
Registration date: 2023-01-16, 1401/10/26
Registration timing: prospective

Last update: 2023-01-16, 1401/10/26
Update count: 0
Registration date
2023-01-16, 1401/10/26
Registrant information
Name
Daniz Montakhabi Oskoui
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 5220
Email address
danizmo1026@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-26, 1401/11/06
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of the educational intervention of emotional regulation strategies based on Gross model on emotion regulation strategies and psycho-social burden of women infected with human papillomavirus
Public title
Evaluation of the effectiveness of the educational intervention of emotional regulation strategies based on Gross model on emotion regulation strategies and psycho-social burden of women infected with human papillomavirus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having written informed consent to participate in the study age range of 15-49 years and married The husband knowing that his wife is infected with HPV disease The husband is infected with HPV disease Having Iranian nationality Being a resident of Urmia Having at least fifth grade literacy Definite diagnosis (by a gynecologist) during the last three months with HPV type The absence of malignant diseases Living with husband
Exclusion criteria:
Occurrence of pregnancy during the study Unwillingness to cooperate in the continuation of the project Not participating in more than two educational intervention sessions Getting divorced and separated from the husband Not having sex during life Having an acute psychological incident such as losing a family member Having mental illnesses such as severe depression and consuming addictive substances during the study and the last 6 months
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
To select participants, the researcher will go to the specialized clinic of Kausar Medical Training Center in Urmia every day of the week. Among the clients of the clinic, women who meet the criteria for entering the study will be selected, then a brief explanation will be given to them about the goals and the work method. If there is no agreement, another person will be replaced. People will be randomly divided into two control groups (50 people) and intervention group (50 people). In this way, closed envelopes will be used for random allocation. Participants pick one envelope from among 100 envelopes in the box, 50 of which contain card "A" and the other 50 contain card "B". If they pick up the "A" card, they will be placed in the intervention group, and if they pick up the "B" card, they will be placed in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants of the intervention group will be trained in 5 sessions of 45-60 minutes with a frequency of once a week, which are in the form of one-person classes, and to prevent the possibility of publishing information, the control group will be questioned first, so no one of the participants in the control and intervention groups will not be aware of the allocation of the study groups.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia University Of Medical Sciences, Emergency Alley, Resalat Blvd., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5175754584
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.UMSU.REC.1401.322

Health conditions studied

1

Description of health condition studied
Human Papillomavirus
ICD-10 code
B97.7
ICD-10 code description
Papillomavirus as the cause of diseases classified to other chapters

Primary outcomes

1

Description
General psycho-social burden score of women infected with human papillomavirus
Timepoint
Measuring the general psycho-social burden score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later
Method of measurement
HIP questionnaire

2

Description
Gross's emotional regulation strategies
Timepoint
Measurement of the Gross's emotional regulation strategies score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later
Method of measurement
Gross's emotion regulation questionnaire

Secondary outcomes

1

Description
Worries and concerns
Timepoint
Measurement of the Worries and concerns score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later.
Method of measurement
HIP questionnaire

2

Description
Emotional impact
Timepoint
Measurement of the emotional impact score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later.
Method of measurement
HIP questionnaire

3

Description
Sexual impact
Timepoint
Measurement of the sexual impact score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later.
Method of measurement
HIP questionnaire

4

Description
Self image
Timepoint
Measurement of the self image score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later.
Method of measurement
HIP questionnaire

5

Description
Partner and transmission
Timepoint
Measurement of the partner and transmission score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later.
Method of measurement
HIP questionnaire

6

Description
Interactions with doctors
Timepoint
Measurement of the interactions with doctors score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later.
Method of measurement
HIP questionnaire

7

Description
Control/life impact
Timepoint
Measurement of the control/life impact score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later.
Method of measurement
HIP questionnaire

8

Description
Cognitive reappraisal
Timepoint
Measurement of the cognitive reappraisal score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later.
Method of measurement
Gross's emotion regulation questionnaire

9

Description
Expressive suppression
Timepoint
Measurement of the expressive suppression score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later.
Method of measurement
Gross's emotion regulation questionnaire

Intervention groups

1

Description
Intervention group: After obtaining the written consent, the demographic information questionnaire, the HIP questionnaire and the Gross Emotion Regulation Scale will be completed through self-reporting. The educational intervention will be carried out based on the educational protocol of Gross's emotional regulation strategies (individually). Participants of the intervention group will be trained in 5 sessions of 45 to 60 minutes with a frequency of once a week, which are in the form of one-on-one classes. In this intervention, educational aids such as PowerPoint, animation and brochures will be used. In the last session of the intervention and three months later, the questionnaires related to the post-test will be presented and completed again.
Category
Behavior

2

Description
Control group: After obtaining the written consent, the demographic information questionnaire, the HIP questionnaire and the Gross Emotion Regulation Scale will be completed through self-reporting. No intervention will be done for this group. At the same time as the last intervention session and 3 months later, questionnaires related to the post-test will also be presented and completed for the control group. At the end of the study and after the completion of the training sessions, in order to maintain mental health and comply with ethical principles, a training session will be conducted for the participants of the control group and training content will be provided to them.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Kousar hospital
Full name of responsible person
Dr. Koroush Ghasemi
Street address
Urmie Obstetrics and Gynecology Hospital ( Kousar Hospital ), Hasani St, Urmia, West Azerbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 5079
Fax
+98 44 3346 5079
Email
verification@umsu.ac.ir
Web page address
https://kosar.umsu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amin Vali Zadeh Hasanlouie
Street address
Urmia University of Medical Sciences, Emergency Alley, Resalat Blvd., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 4150
Fax
+98 44 3346 5079
Email
verification@umsu.ac.ir
Web page address
https://umsu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Roghaye Bayrami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Pardis Nazlou, 11th km of Nazlou Highway, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3223 4897
Fax
+98 44 3222 9059
Email
Rozabayrami@yahoo.com
Web page address
https://nm.umsu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Roghaye Bayrami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Pardis Nazlou, 11th km of Nazlou Highway, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3223 4897
Fax
+98 44 3222 9059
Email
Rozabayrami@yahoo.com
Web page address
https://nm.umsu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Daniz Montakhabi Oskouie
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 82, Shahid Kalantari alley, Manzariyeh alley, Azadi Blvd., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5175754584
Phone
0414795220
Fax
+98 44 3346 5079
Email
danizmo1026@gmail.com
Web page address
https://umsu.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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