This study aimed to determine the effect of expressive writing on anxiety, depression and quality of life in women with Human Papillomavirus infection.
Design
Randomized clinical trial, single-blind with parallel groups, including: one intervention group and one control group (72 participants in each group). Sampling will be continues. The allocation of the participants to each group will be performed using block randomization with blocks of four.
Settings and conduct
At baseline, all participants in both the intervention and control groups will complete the demographic questionnaire, Beck Anxiety Inventory (BAI), Beck Depression Inventory-II (BDI-II), and the WHO Quality of Life questionnaire (WHOQOL-BREF).
Following a 4-week intervention period, participants in both groups will complete the same questionnaires again to assess changes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 45 years old, Iranian nationality, diagnosis of Human Papillomavirus (HPV) infection.
Exclusion criteria: presence of malignant and known diseases,
concurrent sexually transmitted infections, presence of Cervical Intraepithelial Neoplasia Grade 3 (CIN3), consumption of alcohol and drugs, presence of known mental disorders (based on self-report of the participant), occurrence of a stressful event at least 3 months prior.
Intervention groups
The intervention group will be introduced to the intervention implementation method and written expression technique in a training session. Writing should be done using free association without deliberate thought, followed by 30 minutes of writing about their emotions and feelings without concern for spelling or grammar. Control group will be asked to write about their daily activities, once a week for four consecutive weeks, dedicating 30 minutes each session.
Main outcome variables
Depression, anxiety, quality of life.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090810002324N22
Registration date:2025-08-10, 1404/05/19
Registration timing:prospective
Last update:2025-08-10, 1404/05/19
Update count:1
Registration date
2025-08-10, 1404/05/19
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-01, 1404/06/10
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of expressive writing on anxiety, depression and quality of life in women with Human Papillomavirus Infection
Public title
Expressive writing, anxiety, depression and quality of life in women with Human Papillomavirus infection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age Between 18 and 45 years old
Iranian Nationality
Ability to read and write
Definite diagnosis of Human Papilloma virus (HPV), at least 3 months prior (confirmed by HPV test or diagnosis of genital warts ), documented in the patient's file.
Exclusion criteria:
Presence of malignant diseases
Concurrent sexually transmitted infections
Presence of Cervical Intraepithelial Neoplasia Grade 3 (CIN3)
Pregnancy
Breastfeeding
Presence of known mental disorders (based on self-report of the participant)
Consumption of alcohol and drugs
Contact with other individuals with HPV infection attending the clinic or membership in shared online groups
Occurrence of a stressful event at least 3 months prior
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be continuously enrolled in the study. Each of the codes A and B will be assigned to one of the control or experimental groups. The process of assigning individuals to each of the two intervention (n=72) and control (n=72) groups will be done randomly using one of the following blocks of four: AABB, ABAB, ABBA, BBAA, BABA, and BAAB. The blocks will be determined using the R statistical program. For concealment, each block will be placed in an opaque envelope. Each envelope will be randomly selected by one of the study participants.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants and the researcher will be aware of how individuals are assigned to each of the two intervention and control groups. Before and after intervention, in order to blinding, all questionnaires will be presented and collected by a research assistant who is unaware of the allocation method and project objectives. Therefore this study is single-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2025-06-29, 1404/04/08
Ethics committee reference number
IR.IUMS.REC.1404.351
Health conditions studied
1
Description of health condition studied
Human Papillomavirus Infection
ICD-10 code
A63.8
ICD-10 code description
Other specified predominantly sexually transmitted diseases
Primary outcomes
1
Description
The mean score and severity of depression
Timepoint
before the intervention and Immediately after the completion of the intervention.
Method of measurement
The Beck Depression Inventory II(BDI-II)
2
Description
The mean score and severity of anxiety
Timepoint
Before the intervention and Immediately after the completion of the intervention
Method of measurement
The Beck Anxiety Inventory (BAI)
3
Description
The mean score of quality of life
Timepoint
before the intervention and Immediately after the completion of the intervention
Method of measurement
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will practice the expressive writing technique once a week for four consecutive weeks, dedicating 30 minutes each session. Writing should be performed in the morning immediately after waking up, in a quiet environment. Initially, writing should be done using free association without deliberate thought, followed by 30 minutes of writing about their emotions and feelings without concern for spelling or grammar. The expressive writing tasks are as follows:• Day 1: Write about themselves (emotions, characteristics, strengths and weaknesses, goals, and aspirations).• Day 2: Write about their deepest feelings, thoughts, and concerns related to their illness.• Day 3: Write about their most difficult experience related to human papillomavirus (HPV).• Day 4: Write about positive thoughts and expectations regarding the treatment process related to HPV.
Category
Prevention
2
Description
Control group: To ensure consistency between groups participants in the control group will also receive an intervention. They will be asked to write about their daily activitiesو once a week for four consecutive weeks, dedicating 30 minutes each session.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Papilloma Clinic, Lolagar Hospital
Full name of responsible person
Zahra Barjesteh
Street address
Khosh Jonubi Street (between Dampazeshki and Azarbayjan Streets), Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1345943159
Phone
+98 21 6403 3000
Email
hosplo@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
vcm@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
Maryam Keshavarz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery, Rashid Yasemi St., Valiasr St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Email
MKmarkesh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery, Rashid Yasemi St., Valiasr St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Email
MKmarkesh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery, Rashid Yasemi St., Valiasr St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 912 573 2924
Email
MKmarkesh@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available