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IRCT20090810002324N22 IRCT 2025-08-10 Iran University of Medical Sciences Expressive writing, anxiety, depression and quality of life in women with Human Papillomavirus infection The effect of expressive writing on anxiety, depression and quality of life in women with Human Papillomavirus Infection 2026-06-10 anticipated 144 Complete https://irct.ir/trial/83636 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Human Papillomavirus Infection. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Decisions will be made in the future.
public Maryam Keshavarz
School of Nursing & Midwifery, Rashid Yasemi St., Valiasr St., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1139 MKmarkesh@gmail.com Iran University of Medical Sciences scientific Maryam Keshavarz
School of Nursing & Midwifery, Rashid Yasemi St., Valiasr St., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1139 MKmarkesh@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 45 years Female 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 A63.8 Other specified predominantly sexually transmitted diseases Prevention N/A 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. 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. 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). 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). 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). Iran University of Medical Sciences Approved 2025-06-29 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)