Investigating the effect of Great Plantain and Damask Rose gel on the cesarean section wound healing process

Investigating the effect of Great Plantain and Damask Rose gel on the cesarean section wound healing process

The clinical trial with two groups (intervention and control) with a sample size of 88 individuals, pragmatic, double-blind, randomized

This study will investigate the effect of Great Plantain and Damask Rose gel on the cesarean section wound healing process in Afshar Hospital, Yazd City. The outcome assessor and participants will be unaware of the allocation. Patients will be randomly assigned to the intervention group (Great Plantain and Damask Rose gel) and the Placebo group. The response to treatment will be evaluated using the REEDA scale at the end of the first and second weeks.

Women older than 18 years and less than 45 years old, Pregnancy age of more than 37 weeks, Cesarean section delivery, Cesarean section without myomectomy or hysterectomy

Intervention group: Patients will use Great Plantain and Damask Rose gel twice a day on the cesarian section wound for 14 days. The first time to use the gel will be 12 hours after the episiotomy, after washing the wound with serum and drying it. Placebo group: Patients in this group will use a placebo in the same packaging and contents as the medicine of the intervention group and with the same method.

Cesarean section wound healing process (REEDA scale changes)

In this research, the 4 block randomization method is used. The randomization process is done as follows: 1. Definition of groups: First, the studied society is divided into similar groups. In this research, it is expected that the number of participants in each group will be equal. 2. Creating blocks: To create blocks of 4, participants are randomly assigned to 4 groups. Each block consists of 4 people who are randomly divided between experimental and control groups. 3. Random specialization: R software is used to form blocks and distinguish people into different groups (experimental group and control group). Concealment A sealed opaque envelope is used for concealment. 1. Preparation of envelopes: After creating blocks of 4, envelopes containing information about the allocation group (experimental or control) are prepared for each block. 2. The process of opening envelopes: At runtime, envelopes are opened randomly and sequentially. The researcher just opens the envelopes and assigns people to groups blindly. 3. Monitoring and evaluation: The process will be continuously monitored and evaluated to ensure that randomization and concealment are performed correctly.

To effectively reduce potential biases, this study will implement the following steps for blinding: - Participant blinding: Participants will be blinded to their allocation to the intervention or control group throughout the trial, while being aware of the study procedure. - Investigator blinding: Researchers involved in delivering the intervention or collecting data will be blinded to the allocation of participants, so that their interactions with participants and the data collection processes remain unbiased. - Analyst blinding: Personnel responsible for analyzing the results will also be blinded to the group assignments, so that their assessments are not influenced by knowledge of the participants’ group allocation. - To ensure blinding, all individuals involved in the study will be trained in the use of placebo, randomization, and secure data management. There will also be regular monitoring to assess the effectiveness of blinding throughout the trial, by obtaining feedback from participants and looking for any violations.