Comparison of the effect of two methods of individual and couple counseling in reducing anxiety, depression and improving the quality of life of women with HPV
Design
Randomized Clinical trial with control group, one-blind with parallel groups
Settings and conduct
HPV-positive women referred to the gynecological oncology clinic of Valiasr Hospital (located in Imam Khomeini Hospital) are invited to participate in the study. If the company agrees, they will be in the group of individual or couple counseling.
Participants/Inclusion and exclusion criteria
Admission Requirements: positive HPV test result
literacy
Understanding Persian language
No chronic disease and mental illness
Intervention groups
Intervention group 1: This intervention will run virtually and individually in 6 sessions (30 minutes for each session) as a day in between. Telephone counseling to support women with HPV to overcome their fears and worries will be conducted and answering their questions (about 4 times) . An educational intervention based on correcting the myths of the disease will be designed to change misunderstandings and negative perceptions about the disease, eliminate misconceptions and relieve stigma. The second part of the training will be based on lifestyle to strengthen the body immune system (nutrition, exercise, sleep hygiene and sexual health). The educational booklet compiled by the researcher is presented to the patients at the end of the second session for study, which is designed based on a review of the texts and using the opinion of experts.
Intervention group 2: This intervention will run virtually and couple in 6 sessions (30 minutes for each session) as a day in between.
Control group: In the control group, no intervention will be performed by the researcher and patients will receive only routine care.
Main outcome variables
Anxiety and depression in women with HPV
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201012049002N1
Registration date:2021-01-09, 1399/10/20
Registration timing:prospective
Last update:2021-01-09, 1399/10/20
Update count:0
Registration date
2021-01-09, 1399/10/20
Registrant information
Name
Kowsar Qaderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4203
Email address
kowsar.qaderi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-14, 1399/10/25
Expected recruitment end date
2021-01-24, 1399/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of in-person and couples counseling on anxiety, depression and quality of life in HPV-positive women
Public title
Comparison between in-person and couples counseling in reducing anxiety depression and quality of life of HPV positive women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Receiving Positive result of HPV test
Being literate
Understanding Persian language
no chronic illness
no known mental illness
Exclusion criteria:
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization: With the size of blocks 3, 6 and 9, 40 people will be randomly assigned to 3 groups. A member of the research team who is not involved in the selection of samples, will determine the random allocation sequence using a computer program, and opaque envelopes in the package will be numbered in order to allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyst is blinded to the allocation of study groups. In this way, the statistical analyzer does not know which of the data belongs to the control or experimental group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Commitee of School of Nursing and Midwifery and School of Rehabilitation - National Ethics C
Street address
Nursing and Midwifery School, Mirkhani St., Nosrat St., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-10-31, 1397/08/09
Ethics committee reference number
IR.TUMS.FNM.REC.1397.139
Health conditions studied
1
Description of health condition studied
Anogenital (venereal) warts
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts
2
Description of health condition studied
Mild cervical dysplasia
ICD-10 code
N87.0
ICD-10 code description
Mild cervical dysplasia
Primary outcomes
1
Description
Anxiety and Depression
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
Secondary outcomes
1
Description
Quality of life
Timepoint
Before and 10 weeks after intervention
Method of measurement
QoL SF-36
Intervention groups
1
Description
Intervention group 1: This intervention will run virtually and individually in 6 sessions (30 minutes for each session) as a day in between. Telephone counseling to support women with HPV to overcome their fears and worries will be conducted and answering their questions (about 4 times) . Six training sessions consist of two parts, each of which will be three sessions: In the first part, an educational intervention based on correcting the myths of the disease will be designed to change misunderstandings and negative perceptions about the disease, eliminate misconceptions and relieve stigma. The second part of the training will be based on lifestyle to strengthen the body immune system and eliminate the virus from the body (nutrition, exercise, sleep hygiene and sexual health). The educational booklet compiled by the researcher is presented to the patients at the end of the second session for study, which is designed based on a review of the texts and using the opinion of experts.
Category
Lifestyle
2
Description
Intervention group 2: This intervention will run virtually and couple in 6 sessions (30 minutes for each session) as a day in between. Telephone counseling to support women with HPV to overcome their fears and worries will be conducted and answering their questions (about 4 times) . Six training sessions consist of two parts, each of which will be three sessions: In the first part, an educational intervention based on correcting the myths of the disease will be designed to change misunderstandings and negative perceptions about the disease, eliminate misconceptions and relieve stigma. The second part of the training will be based on lifestyle to strengthen the body immune system and eliminate the virus from the body (nutrition, exercise, sleep hygiene and sexual health). The educational booklet compiled by the researcher is presented to the patients at the end of the second session for study, which is designed based on a review of the texts and using the opinion of experts.
Category
Lifestyle
3
Description
Control group: In the control group, no intervention will be performed by the researcher and patients will receive only routine care. After the trial, educational content will be provided to them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr gynecology oncology clinic at Imam Khomeini Hospital
Full name of responsible person
Kowsar Qaderi
Street address
Imam Khomeini Hospital, Mirkhani St., Nosrat St., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6119 2993
Email
kqaderi@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
North Door, Poursina St.,, Ghods St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
m.sahrai@sina.tums.ac.it
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh Tahereh Mirmolaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School, Mirkhani St., Nosrat St., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
mirmolaei@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kowsar Qaderi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School, Mirkhani St., Nosrat St., Tehran
City
Tehran
Province
Tehran
Postal code
61054000
Phone
+98 21 6105 4000
Email
kqaderi@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kowsar Qaderi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School, Mirkhani St., Nosrat St., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
kowsar.qaderi@gmail.com
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