The effect of combining alum ointment and positive psychology on episiotomy healing and pain intensity in primiparous women

Determining the effect of alum ointment and positive psychology on the healing and pain intensity of episiotomy in primiparous women

A phase 3 clinical trial without a control group, using factorial groups, was conducted on 120 patients. Randomization was performed using an online system.

The procedure involves visiting selected teaching hospitals in the city of Rasht—upon presentation of a written letter of introduction—to collect samples. Al-Zahra Teaching Hospital, a public facility serving as a referral center for patients from other counties in the province, will be included. Subsequently, all samples will be enrolled in the study using a randomized block design (block size of 12).

Inclusion criteria: Primiparous, literate women with gestational age of 38–42 weeks, BMI between 18.5–24.9, infant weight 2500–4000 g, vaginal delivery with mediolateral episiotomy without instruments, no prolonged membrane rupture, chronic constipation, or psychiatric disorders. Exclusion criteria: Unwillingness to participate, substance abuse or psychoactive drug use, incorrect ointment use, sensitivity to alum ointment, use of wound-healing drugs, episiotomy manipulation, sexual activity within 10 days postpartum, missing follow-ups, perineal injury history, chronic diseases, hospitalized or abnormal infant, or absence from more than two counseling sessions.

In this study, the intervention will involve a combination of 2% alum ointment and positive psychology therapy.

Primary outcome: Pain measured by REEDA and Visual Analogue Scale (VAS) at 4, 8, 12 hours, and days 5 and 10 post-intervention. Secondary outcomes: Wound healing and adverse effects assessed by a researcher-made questionnaire at the same intervals.

Due to a change in the study location, information regarding the randomization method and other details related to the research site has been updated.

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.