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IRCT20250915067251N1 IRCT 2025-09-25 Kerman University of Medical Sciences The effect of combining alum ointment and positive psychology on episiotomy healing and pain intensity in primiparous women The effect of combining alum ointment and positive psychology on episiotomy healing and pain intensity in primiparous women 2025-09-23 anticipated 120 Complete https://irct.ir/trial/86205 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: In this study, four groups of primiparous women will be assigned to three intervention groups and one control group. A total of 120 primiparous women undergoing vaginal delivery with episiotomy will be recruited from selected teaching hospitals in Rasht. Random assignment will be conducted using blocks of 12 with a 1:1:1:1 allocation ratio. Randomization will be performed via the online system at https://www.sealedenvelope.com/simple-randomiser/v1/lists. A total of ten blocks of 12 will be used to generate the 120 randomized assignments. Eligible participants will be assigned to the respective groups sequentially according to the list. The intervention assignments will be numbered and placed in sealed envelopes. Given the nature of the interventions in this study (counseling, herbal ointment, and placebo), complete blinding across all groups is not feasible. However, the following measures have been implemented to minimize the risk of bias: Blinding of participants in the ointment groups: The two types of ointment (herbal and placebo) have been designed to be identical in appearance, color, odor, packaging, and method of application, ensuring that neither the participants nor the researchers responsible for outcome assessment are aware of the specific ointment type (herbal or placebo) being used. Thus, double-blinding is maintained for this part of the study. Counseling group: Due to the fundamental difference between this intervention (counseling) and those of the other groups, blinding is not possible for this group. However, the statistical analyst and the assessors of the final results will remain unaware of the participants' group assignments (analyst blinding). Overall, the study is designed as a single-blind trial, with blinding of participants across the treatment groups and the final data analyst to minimize potential bias in the interpretation of results. For each block of eight individuals, the randomization sequence for group assignments (A, B, C, D) was placed together in a numbered, sealed envelope; each envelope contained the assignments for eight participants. As each participant enrolled, the envelope corresponding to their sequence number was opened to determine their assigned group. 3 The effect of combining alum ointment and positive psychology on episiotomy healing and pain intensity in primiparous women. Intervention 1: Intervention group:The intervention consists of applying alum ointment twice daily for 10 days as topical treatment. Intervention 2: Intervention group:Participants will receive alum ointment along with positive psychology counseling. First, they will attend one individual face-to-face psychotherapy session lasting 30 to 45 minutes at the hospital. Then, they will be treated with the topical ointment twice daily for 10 days, while simultaneously receiving 10 sessions of 45-minute positive psychology counseling via virtual meetings. Intervention 3: Intervention group: Positive psychology counseling begins with an initial individual face-to-face session lasting 30 to 45 minutes at the hospital. Intervention 4: Control group: Placebo ointment: Participants will be treated with the topical ointment twice daily for 10 days. This ointment is similar in shape and appearance to the alum ointment. 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 At this stage, no final decision has been made regarding the sharing of individual participant data (IPD) that are de-identified. This matter will be considered after the completion of the study, final data analysis, and careful review of ethical and legal considerations. If a decision is made to share the data, detailed information regarding the method, timing, conditions, and extent of access will be transparently disclosed.
public Hasti Shenasandeh
Unit 3, No.9,Azadkhoo Alley, Sq 40,Narmak
تهران Iran (Islamic Republic of) ۱۶۴۷۶۱۷۱۸۱ +98 21 7725 4509 hastishenasandeh@gmail.com Kerman University of Medical Sciences scientific Hasti Shenasandeh
Unit 3, No.9,Azadkhoo Alley, Sq 40,Narmak
تهران Iran (Islamic Republic of) ۱۶۴۷۶۱۷۱۸۱ +98 21 7725 4509 hastishenasandeh@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Ability to read and write Being a primiparous woman Gestational age between 38 and 42 completed Body mass index (BMI) in the range of 18.5 to 24.9 Newborn weight between 2500 and 4000 grams Vaginal delivery with mediolateral No rupture of membranes for more than 18 hours No simultaneous psychiatric or psychological interventions No chronic constipation Absence of any significant psychiatric disorders,anxiety ,depression or neuropsychological symptoms no limit no limit Female Addiction to drugs or use of psychoactive substances Allergy to alum ointment Use of medications that affect wound healing during the study Re-manipulation of the episiotomy site after initail repair Engaging in sexual intercourse within the first 10 days postpartum failure to return to the hospital one days 5 and 10 for episiotomy healing assessment History of trauma or previous surgery,and presence of visible perineal Having diseases that interfere with wound healing, such as chronic illnesses ,heart, kidney or lung disease ,connective tissue disorders, diabetes, anemia, hemophilia or malnutrition Neonatal hospitalization or presence of congenital abnormalities in the newborn Missing more than two counseling sessions O70 Perineal laceration during delivery Treatment - Drugs Treatment - Other Treatment - Other Other Intervention group:The intervention consists of applying alum ointment twice daily for 10 days as topical treatment. Intervention group:Participants will receive alum ointment along with positive psychology counseling. First, they will attend one individual face-to-face psychotherapy session lasting 30 to 45 minutes at the hospital. Then, they will be treated with the topical ointment twice daily for 10 days, while simultaneously receiving 10 sessions of 45-minute positive psychology counseling via virtual meetings. Intervention group: Positive psychology counseling begins with an initial individual face-to-face session lasting 30 to 45 minutes at the hospital. Control group: Placebo ointment: Participants will be treated with the topical ointment twice daily for 10 days. This ointment is similar in shape and appearance to the alum ointment. The primary outcome of the present study is pain. Timepoint: It is measured at intervals of 4, 8, and 12 hours, and on days 5 and 10 after the intervention. Method of measurement: Through the REDA scale and the visual pain scale. Healing of the episiotomy wound is considered a secondary outcome. Timepoint: It is completed at intervals of 4, 8, and 12 hours, and on days 5 and 10 after the intervention. Method of measurement: Adverse effects are assessed using a self-designed questionnaire. Kerman University of Medical Sciences Approved 2025-09-15 Ethics Committee of Kerman University of Medical Sciences Unit 3, No. 9,Azadkhoo Alley, Sq 40, Narmak Tehran Tehran Iran (Islamic Republic of)