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 sampling method is multi-stage: 15 teaching hospitals are randomly chosen from three medical universities in Tehran. Then, 8 patients per hospital are randomly selected using block randomization. The total sample size is 120. The population includes primiparous women with vaginal delivery and episiotomy in Tehran teaching hospitals.

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.

In this study, four groups of primiparous pregnant women will be assigned to three intervention groups and one control group. A total of 120 primiparous women who undergo vaginal delivery with episiotomy at selected teaching hospitals in Tehran will be recruited. Block randomization with blocks of eight and an allocation ratio of 1:1:1:1 will be used. Randomization will be carried out using the online system available at https://www.sealedenvelope.com/simple-randomiser/v1/lists. In total, 15 blocks of eight will be used to generate the 120 random assignments. Eligible participants will be assigned to each group in order according to the list. The type of intervention will be coded and placed in sealed envelopes. In this study, 120 participants were randomly assigned to four different groups. The allocation method was based on block randomization, with each block consisting of eight participants. All possible arrangements of the representative letters for the groups (A, B, C, D) within blocks of eight were initially considered. These arrangements resulted in a total of 70 unique patterns, each numbered from 1 to 70. Based on the total sample size, the number of required blocks was calculated. Then, using a random number table and considering the number of blocks needed, the corresponding block numbers were selected and assigned to participants in sequence. For example, block number 4 with the pattern “AABBCCDD” was assigned to participants numbered 57 to 64. (The randomization list is attached.) For allocation concealment, the random assignment sequence for each 8-person block (A, B, C, D) was placed inside a single sealed and numbered envelope. Each envelope contained the allocation information for eight participants. As each participant enrolled, the next assignment inside the envelope was opened in sequence, and the group to which the individual was assigned was revealed