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Protocol summary
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.
Randomized clinical trial, single-blind with parallel groups, including: one intervention group and one control group (72 participants in each group). Sampling will be simple random sampling. The allocation of individuals to the two groups will be done using the randomization website.
Randomized clinical trial, single-blind with parallel groups, including: one intervention group and one control group (72 participants in each group). Sampling will be continuessimple random sampling. The allocation of the participantsindividuals to each groupthe two groups will be performeddone using blockthe randomization with blocks of fourwebsite.
کارآزمایی بالینی تصادفی، یه سویه کور با گروه های موازی، شامل:یک گروه آزمون و یک گروه کنترل است (درهر گروه 72 شرکت کننده). نمونه‌گیری به صورت مداوم انجام خواهد شد. تخصیص افراد به هر گروه با استفاده از بلوک های تصادفی 4 تایی انجام خواهد شد.
کارآزمایی بالینی تصادفی، یه سویه کور با گروه های موازی، شامل: یک گروه آزمون و یک گروه کنترل است (درهر گروه 72 شرکت کننده). نمونه‌گیری به تصادفی ساده انجام خواهد شد. فهرست اسامی به صورت تصادفی به دو گروه آزمون و کنترل تقسیم خواهد شد. تخصیص افراد به دو گروه با استفاده از وب سایت تصادفی سازی انجام خواهد شد.
کارآزمایی بالینی تصادفی، یه سویه کور با گروه های موازی، شامل:یک گروه آزمون و یک گروه کنترل است (درهر گروه 72 شرکت کننده). نمونه‌گیری به تصادفی ساده انجام خواهد شد. فهرست اسامی به صورت مداوم انجامتصادفی به دو گروه آزمون و کنترل تقسیم خواهد شد. تخصیص افراد به هردو گروه با استفاده از بلوک هایوب سایت تصادفی 4 تاییسازی انجام خواهد شد.
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.
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 2 months prior.
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 32 months prior.
معیار های ورود: سن 18 تا 45 سال، ملیت ایرانی، ابتلا به عفونت ویروس پاپیلوما.
معیار های خروج: ابتلا به بیماری های بدخیم و شناخته شده، ابتلا همزمان به سایر بیماری های مقاربتی، ابتلا به نئوپلازی اینتراپیتلیال دهانه رحم درجه 3، مصرف الکل و مواد مخدر، ابتلا به اختلالات روانی شناخته شده (به اظهار و گفته ی فرد شرکت کننده)، وقوع حادثه تنش زا حداقل از 3 ماه قبل.
معیار های ورود: سن 18 تا 45 سال، ملیت ایرانی، ابتلا به عفونت ویروس پاپیلوما.
معیار های خروج: ابتلا به بیماری های بدخیم و شناخته شده، ابتلا همزمان به سایر بیماری های مقاربتی، ابتلا به نئوپلازی اینتراپیتلیال دهانه رحم درجه 3، مصرف الکل و مواد مخدر، ابتلا به اختلالات روانی شناخته شده (به اظهار و گفته ی فرد شرکت کننده)، وقوع حادثه تنش زا حداقل از 2 ماه قبل.
معیار های ورود: سن 18 تا 45 سال، ملیت ایرانی، ابتلا به عفونت ویروس پاپیلوما. معیار های خروج: ابتلا به بیماری های بدخیم و شناخته شده، ابتلا همزمان به سایر بیماری های مقاربتی، ابتلا به نئوپلازی اینتراپیتلیال دهانه رحم درجه 3، مصرف الکل و مواد مخدر، ابتلا به اختلالات روانی شناخته شده (به اظهار و گفته ی فرد شرکت کننده)، وقوع حادثه تنش زا حداقل از 32 ماه قبل.
General information
2025-09-01, 1404/06/10
2026-06-10, 1405/03/20
20252026-0906-0110 00:00:00
2026-03-11, 1404/12/20
2026-09-11, 1405/06/20
2026-0309-11 00:00:00
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According to the beginning of the war, sampling time, sampling location, and sampling type were changed.
According to the beginning of the war, sampling time, sampling location, and sampling type were changed.
empty
با توجه به شروع جنگ، زمان نمونه گیری، محل نمونه گیری و نوع نمونه گیری تغییر یافت.
با توجه به شروع جنگ، زمان نمونه گیری، محل نمونه گیری و نوع نمونه گیری تغییر یافت.
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
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 2 months prior
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 32 months prior
ابتلا به بیماری های بدخیم
ابتلا همزمان به سایر بیماری های مقاربتی
ابتلا به نئوپلازی اینتراپیتلیال دهانه رحم درجه 3
بارداری
شیردهی
ابتلا به اختلالات روانی شناخته شده (به اظهار و گفته ی فرد شرکت کننده)
مصرف الکل و مواد مخدر
ارتباط با سایر افراد مبتلا به عفونت ویروس پاپیلومای انسانی مراجعه کننده به کلینیک یا عضویت درگروه های مجازی مشترک
وقوع حادثه تنش زا حداقل از 3 ماه قبل
ابتلا به بیماری های بدخیم
ابتلا همزمان به سایر بیماری های مقاربتی
ابتلا به نئوپلازی اینتراپیتلیال دهانه رحم درجه 3
بارداری
شیردهی
ابتلا به اختلالات روانی شناخته شده (به اظهار و گفته ی فرد شرکت کننده)
مصرف الکل و مواد مخدر
ارتباط با سایر افراد مبتلا به عفونت ویروس پاپیلومای انسانی مراجعه کننده به کلینیک یا عضویت درگروه های مجازی مشترک
وقوع حادثه تنش زا حداقل از 2 ماه قبل
ابتلا به بیماری های بدخیم ابتلا همزمان به سایر بیماری های مقاربتی ابتلا به نئوپلازی اینتراپیتلیال دهانه رحم درجه 3 بارداری شیردهی ابتلا به اختلالات روانی شناخته شده (به اظهار و گفته ی فرد شرکت کننده) مصرف الکل و مواد مخدر ارتباط با سایر افراد مبتلا به عفونت ویروس پاپیلومای انسانی مراجعه کننده به کلینیک یا عضویت درگروه های مجازی مشترک وقوع حادثه تنش زا حداقل از 32 ماه قبل
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.
Initially, the clinic manager will provide the researcher with the contact numbers of individuals who meet the inclusion criteria. The list of names will be randomly divided into two groups: experimental and control. The allocation of individuals to the two groups will be done using the randomization website (www.randomizer.org).
Eligible participantsInitially, the clinic manager will provide the researcher with the contact numbers of individuals who meet the inclusion criteria. The list of names will be continuously enrolled in the study. Each of the codes Arandomly divided into two groups: experimental and B will be assigned to one of the control or experimental groups. The processallocation 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 programrandomization website (www.randomizer.org). For concealment, each block will be placed in an opaque envelope. Each envelope will be randomly selected by one of the study participants.
شرکت‌کنندگان واجد شرایط به طور مداوم در مطالعه وارد خواهند شد. هر یک از کدهای A و B به یکی از گروه‌های کنترل یا آزمون اختصاص داده خواهد شد. فرآیند اختصاص افراد به هر یک از دو گروه مداخله (72 نفر) و کنترل (72 نفر) به صورت تصادفی و با استفاده از یکی از بلوک‌های چهارتایی زیر انجام خواهد شد: AABB، ABAB، ABBA، BBAA، BABA و BAAB. بلوک‌ها با استفاده از برنامه آماری R تعیین می‌شوند.جهت پنهان سازی، هر یک از بلوک ها در یک پاکت مات قرار می گیرند. هر پاکت به طور تصادفی و توسط یکی از شرکت کنندگان در مطالعه انتخاب خواهد شد.
در ابتدا، مسول کلینیک شماره تماس افراد دارای معیارهای ورود را در اختیار محقق قرار خواهدداد. فهرست اسامی به صورت تصادفی به دو گروه آزمون و کنترل تقسیم خواهد شد. تخصیص افراد به دو گروه با استفاده از وب سایت تصادفی سازی (www.randomizer.org) انجام خواهد شد.
شرکت‌کنندگان واجد شرایط به طور مداومدر ابتدا، مسول کلینیک شماره تماس افراد دارای معیارهای ورود را در مطالعه وارد خواهند شداختیار محقق قرار خواهدداد. هر یک از کدهای A و B به یکی از گروه‌های کنترل یا آزمون اختصاص داده خواهد شد. فرآیند اختصاص افراد به هر یک از دو گروه مداخله (72 نفر) و کنترل (72 نفر)فهرست اسامی به صورت تصادفی به دو گروه آزمون و کنترل تقسیم خواهد شد. تخصیص افراد به دو گروه با استفاده از یکی از بلوک‌های چهارتایی زیروب سایت تصادفی سازی (www.randomizer.org) انجام خواهد شد: AABB، ABAB، ABBA، BBAA، BABA و BAAB. بلوک‌ها با استفاده از برنامه آماری R تعیین می‌شوند.جهت پنهان سازی، هر یک از بلوک ها در یک پاکت مات قرار می گیرند. هر پاکت به طور تصادفی و توسط یکی از شرکت کنندگان در مطالعه انتخاب خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: Papilloma Clinic, Lolagar Hospital
Name of recruitment center - Persian: کلینیک پاپیلومای لولاگر
Full name of responsible person - English: Zahra Barjesteh
Full name of responsible person - Persian: زهرا برجسته
Street address - English: Khosh Jonubi Street (between Dampazeshki and Azarbayjan Streets), Tehran, Iran
Street address - Persian: تهران، خيابان خوش جنوبي، بين خيابان دامپزشكي و آذربايجان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1345943159
Phone: +98 21 6403 3000
Fax:
Email: hosplo@iums.ac.ir
Web page address:
Name of recruitment center - English: Papilloma Clinic, Shahid Motahari Hospital
Name of recruitment center - Persian: کلینیک پاپیلوما، بیمارستان شهید مطهری
Full name of responsible person - English: Zahra Barjesteh
Full name of responsible person - Persian: زهرا برجسته
Street address - English: Valiasr Street, above Mirdamad Street, Shahid Rashid Yasemi Street, Tehran, Iran.
Street address - Persian: تهران ، خیابان ولیعصر ، بالاتر از خیابان میرداماد ، خیابان شهید رشید یاسمی ، مرکز آموزشی درمانی شهید مطهری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1345943159
Phone: +98 21 6403 3000
Fax:
Email: hosplo@iums.ac.ir
Web page address:
Name of recruitment center - English: Papilloma Clinic, LolagarShahid Motahari Hospital Name of recruitment center - Persian: کلینیک پاپیلومای لولاگرپاپیلوما، بیمارستان شهید مطهری Full name of responsible person - English: Zahra Barjesteh Full name of responsible person - Persian: زهرا برجسته Street address - English: Khosh JonubiValiasr Street (between Dampazeshki and Azarbayjan Streets), above Mirdamad Street, Shahid Rashid Yasemi Street, Tehran, Iran. Street address - Persian: تهران، خيابان خوش جنوبيخیابان ولیعصر ، بين خيابان دامپزشكي و آذربايجانبالاتر از خیابان میرداماد ، خیابان شهید رشید یاسمی ، مرکز آموزشی درمانی شهید مطهری City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1345943159 Phone: +98 21 6403 3000 Fax: Email: hosplo@iums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Majid Safa
Full name of responsible person - Persian: مجید صفا
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 86701
Fax:
Email: vcm@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Majid Safa
Full name of responsible person - Persian: مجید صفا
Street address - English: Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran.
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 86701
Fax:
Email: vcm@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Majid Safa Full name of responsible person - Persian: مجید صفا Street address - English: Iran University of Medical Sciences, Shahidnext to Milad Tower, Hemmat Highway, Tehran, Iran. Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 86701 Fax: Email: vcm@iums.ac.ir Web page address:
Protocol summary
Study aim
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 simple random sampling. The allocation of individuals to the two groups will be done using the randomization website.
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 2 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
According to the beginning of the war, sampling time, sampling location, and sampling type were changed.
Acronym
IRCT registration information
IRCT registration number:IRCT20090810002324N22
Registration date:2025-08-10, 1404/05/19
Registration timing:prospective
Last update:2026-06-20, 1405/03/30
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
2026-06-10, 1405/03/20
Expected recruitment end date
2026-09-11, 1405/06/20
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 2 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
Initially, the clinic manager will provide the researcher with the contact numbers of individuals who meet the inclusion criteria. The list of names will be randomly divided into two groups: experimental and control. The allocation of individuals to the two groups will be done using the randomization website (www.randomizer.org).
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, next to Milad Tower, Hemmat Highway, Tehran, Iran.
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.