The effect of health promotion awareness counseling with stress management on anxiety and reproductive and sexual self-care performance in women with human papiloma virus : a controlled clinical randomized trial
Determining the effect of health awareness counseling with a stress management approach on anxiety and fertility and sexual self-care performance in women with genital warts.
Design
A randomized controlled clinical trial with parallel groups of 64 women who have a positive HPV test result and referred to the oncology clinic of Al-Zahra Hospital.
Settings and conduct
Sampling will be done in the specialized clinic of Al-Zara Hospital in Tabriz, after reviewing the inclusion criteria, eligible individuals will complete and sign a written informed consent form. Other research questionnaires including demographics-midwifery, self-care and reproductive and sexual health literacy and quality of life and stress will be completed for both groups in a self administered manner.
Participants/Inclusion and exclusion criteria
inclusion criteria. Women with positive HPV test results and low-risk and high-risk groups with an anxiety score of 32-64. Having a contact number for follow-up. Reading and writing literacy
Exclusion criteria. cancer disease or its history, history of participation in previous educational and intervention programs related to sexual health and fertility, mental disability, any mental illness according to the individual's statement.Any recent unfortunate incident including the loss of a loved one within the last 6 months
Intervention groups
For the intervention group (32 people), six group counseling sessions (4-6 people) will be held for 60-90 minutes in one of the clinic rooms of Al-Zara Hospital. The control group will receive routine care.
Main outcome variables
anxiety score, performance score of reproductive and sexual self-care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111122008170N14
Registration date:2024-01-29, 1402/11/09
Registration timing:prospective
Last update:2024-01-29, 1402/11/09
Update count:0
Registration date
2024-01-29, 1402/11/09
Registrant information
Name
Jamileh Malakouti
Name of organization / entity
Nursing Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 2699
Email address
malakoutij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-12, 1402/11/23
Expected recruitment end date
2024-04-23, 1403/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of health promotion awareness counseling with stress management on anxiety and reproductive and sexual self-care performance in women with human papiloma virus : a controlled clinical randomized trial
Public title
The effect of health promotion awareness counseling with stress management on anxiety and reproductive and sexual self-care performance in women with human papiloma virus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with positive HPV test results and low-risk and high-risk groups
Anxiety score 32-64
Having a contact number for follow-up
Literacy for reading and writing
Exclusion criteria:
Cancer disease or its history
History of participating in previous training and intervention programs related to sexual health and fertility
intellectual disability
Any mental illness according to the person's statement
Any recent unfortunate incident including the loss of a loved one within the last 6 months
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The women participating in the research will be assigned to two groups receiving counseling and the control group through 4 and 6 blocks with a ratio of 1:1 through 4 and 6 blocks using RAS software. The type of allocation will be written on paper and will be provided to the responsible author (the first guidance teacher) and the allocation of people to the intervention and control groups will be done by the same person in a central way (allocation concealment).
Blinding (investigator's opinion)
Single blinded
Blinding description
The person analyzing the data will not be aware of the type of group assignment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht Street, Tabriz University of Medical Sciences Vice President of Research and Technology
City
tabriz
Province
East Azarbaijan
Postal code
51665118
Approval date
2024-01-10, 1402/10/20
Ethics committee reference number
IR.TBZMED.REC.1402.772
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Average anxiety score
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Spielberger anxiety questionnaire
2
Description
Mean score of fertility and sexual self-care performance
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
assessment questionnaire Reproductive and sexual self-care
Secondary outcomes
1
Description
Sexual health literacy
Timepoint
Before the intervention and 4 weeks after the study
Method of measurement
Sexual health literacy questionnaire for adults, SHALE
2
Description
Quality of Life
Timepoint
Before the intervention and 4 weeks after the study
Method of measurement
Quality of life questionnaire for women with HPV (HPV‑QoL Human Papilloma Viral questionnaire)
3
Description
Stress
Timepoint
Before the intervention and 4 weeks after the study
Method of measurement
DASS-21 questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: For the intervention group (32 people), six group counseling sessions (4-6 people) will be held for 60-90 minutes in one of the clinic rooms of Al-Zahra Hospital. In between the counseling sessions, the researcher will be in contact with the participants through telephone follow-ups so that they can participate in the counseling sessions on a regular basis. The researcher will provide his contact number to both intervention and control groups to answer the questions. The control group will receive routine care. If the positive effect of this approach in reducing anxiety and improving self-care performance in the intervention group is confirmed at the end of the study, counseling sessions will also be provided for the control group. The post-test questionnaires including Spielberger's anxiety, self-care and reproductive and sexual health literacy, and quality of life and stress will be completed by self-administered method. In case of incomplete participation in counseling sessions, the questionnaires will be completed and analyzed as Intention to Threat. Also, the missing cases will be investigated with the multiple imputation policy.
Category
Other
2
Description
Control group: . The control group will receive routine care. If the positive effect of this approach in reducing anxiety and improving self-care performance in the intervention group is confirmed at the end of the study, counseling sessions will also be provided for the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital super specialty clinic and clinic
Full name of responsible person
Maryam Vaez
Street address
East Azarbaijan - Tabriz city - South Army street - Baghshamal intersection - Al-Zahra educational and treatment center (S
City
tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
alzahrahospital@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
East Azarbaijan - Tabriz city - South Army street - Baghshamal intersection - Al-Zahra educational and treatment center
City
tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3556 6449
Email
alzahrahospital@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
malakouti.jamileh
Position
master of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati Street, Faculty of Nursing and Midwifery
City
tabriz
Province
East Azarbaijan
Postal code
66156-15733
Phone
+98 41 3479 6770
Email
jamilehmalakouti@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Malakouti.Jamileh
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, South Shariati Street, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
66156-15733
Phone
+98 41 3479 6770
Email
jamilehmalakouti@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Jamileh Malakouti
Position
Assistance professor of Tabriz University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati Street / School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
hajmalakouti@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