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Comparison of the Effectiveness of an Empowerment Intervention on Health Anxiety and Sexual Distress in HPV Positive Women: A Clinical Trial

Protocol summary

Study aim
Determining the effectiveness of an empowerment intervention on health anxiety and sexual distress in HPV positive women.
Design
Experimental study with control group, with parallel groups, without blinding, randomized, on 112 participants, random number table is used for randomization.
Settings and conduct
Women with HPV referring to the papilloma clinic of Lulager Hospital will be selected if they meet the entry criteria and will be randomly assigned to one of the intervention or control groups. After obtaining informed consent, demographic information, health anxiety (HAI-18) and sexual distress (FSDS-R) questionnaires will be completed by the participants. Then, counseling training sessions will be held in person for the intervention group. Questionnaires will be completed 4 weeks after the end of the intervention. Then the collected data will be analyzed and the results will be interpreted.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with a positive high-risk HPV test (with or without low-risk strains) with normal cytology in the last 2 weeks, no history of HPV infection and receiving the HPV vaccine, sexually active, being of reproductive age, not pregnant or breastfeeding. Absence of other diseases in the medical record, especially neurological and mental diseases such as depression and the use of related drugs.
Intervention groups
Two groups will participate in this research. For the women of the intervention group, two 90-minute group training and counseling sessions will be held one week apart, and questions will be answered at the end of each session. For the control group, during the implementation of the research, only the usual interventions will be carried out, but after the end of the research, they will be invited to participate in the empowerment program.
Main outcome variables
Health anxiety; Sexual distress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150128020854N14
Registration date: 2024-07-03, 1403/04/13
Registration timing: registered_while_recruiting

Last update: 2024-07-03, 1403/04/13
Update count: 0
Registration date
2024-07-03, 1403/04/13
Registrant information
Name
Hedyeh Riazi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 386 5612
Email address
h.riazi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of an Empowerment Intervention on Health Anxiety and Sexual Distress in HPV Positive Women: A Clinical Trial
Public title
Comparison of the Effectiveness of an Empowerment Intervention on Health Anxiety and Sexual Distress in HPV Positive Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have Iranian nationality. At least they should be able to read and write. Be at the reproductive age. Lack of speech, hearing or mental disorders that prevent communication with the researcher. Have a positive high-risk HPV test (with or without low-risk strains) with normal cytology in the last 2 weeks. Do not have a history of HPV infection. (According to the statement of the women) Do not have a history of receiving the HPV vaccine. Have sexual activity. Do not be in pregnancy or breastfeeding period. Suffering from other diseases is not mentioned in their medical records. Do not have a history of suffering from neurological and mental diseases such as depression and taking related drugs. (According to the statement of the women) Lack of specific event or incident that represents a crisis in their life, such as death or incurable illness of family members and loss of job since 6 months ago and marital infidelity, and not being on the verge of divorce.
Exclusion criteria:
Have a positive low-risk HPV test without high-risk strains. Have abnormal cytology. Have a history of HPV infection or HPV vaccine. Have a disease other than HPV. do not want to participate in the study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
112 women infected with human papilloma virus referring to the papilloma clinic of Lolagar Hospital in Tehran will be selected according to the research inclusion criteria and then will be assigned randomly to 2 groups of 56. For randomization, three-digit codes from 001 to 112 will be given to participating women. Then, using the website www.Randomization.com, two series of codes will be selected for each group, the first series will be in the intervention group and the second series will be 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 Shahid Beheshti University of Medical Sciences, School of Nursing and Midwifery
Street address
Vali-e-Asr St. - Niayesh Intersection - In front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-05-05, 1403/02/16
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.009

Health conditions studied

1

Description of health condition studied
Human papillomavirus
ICD-10 code
A63
ICD-10 code description
Other predominantly sexually transmitted diseases, not elsewhere classified

2

Description of health condition studied
Health anxiety
ICD-10 code
F45.2
ICD-10 code description
Hypochondriacal disorders

3

Description of health condition studied
Sexual distress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

Primary outcomes

1

Description
Health Anxiety
Timepoint
Before the intervention, 4 week after intervention
Method of measurement
Short Health Anxiety Inventory (SHAI)

2

Description
Sexual Distress
Timepoint
Before the intervention, 4 week after intervention
Method of measurement
The Female Sexual Distress Scale-Revised (FSDS-R)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For women in the intervention group, two 90-minute group training and counseling sessions will be held one week apart. The number of participants in each group will be 10 people.The general contents that are discussed in empowerment sessions mainly include the following:General information about HPV, how it is contracted, screening tests, diagnostic methods, complications, ways of transmission, problems after diagnosis, prognosis, ways to deal with the disease, how to deal with a positive test, how to reduce the physical and mental burden of the disease. How to live after a positive test, disease prevention methods and follow-up.Questions will be answered at the end of each session. Questionnaires of health anxiety and sexual distress will be completed by the participants before the start of the intervention and 4 weeks after the end of the intervention.
Category
Other

2

Description
Control group: For the control group, during the implementation of the research, only the usual interventions will be carried out, but after the end of the research, they will be invited to participate in the empowerment program.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Lulager Hospital Papilloma Clinic
Full name of responsible person
Angila Ataei-Pirkooh
Street address
Papilloma Clinic, Lolagar Hospital, between Dampzashki and Azarbayjan streets, Khosh South Street, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 4603 3363
Email
hosplo.iums.ac.ir@gmail.com
Web page address
https://hosplo.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sepideh Hajian
Street address
Vali-e-Asr St- Niayesh Intersection- In front of Shahid Rajaei Heart Hospital- School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
s.hajian@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Sabzalian
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vali-e-Asr St- Niayesh Intersection- In front of Shahid Rajaei Heart Hospital- School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
h.sabzalian@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hedyeh Riazi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vali-e-Asr St - Niayesh Intersection- In front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
h.riazi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Sabzalian
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vali-e-Asr St- Niayesh Intersection- In frort of Shahid Rajaei Heart Hospital- School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
h.sabzalian@sbmu.ac.ir

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
If there is a logical reason, it will be provided to the journal for publication of the article.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic characteristics and findings related to the main outcome variable will be published in the paper.
When the data will become available and for how long
After the publication of the paper
To whom data/document is available
Researchers
Under which criteria data/document could be used
other statistical analysis
From where data/document is obtainable
Dr. Hedyeh Riazi h.riazi@sbmu.ac.ir
What processes are involved for a request to access data/document
After counseling with the research team, the data will be provided to the applicant, which will be probably a one-month process
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