“Effect of Jujube Fruit Lotion on Pain intensity and Episiotomy Wound Healing in Postpartum Women at Allameh Behlol Gonabadi and Hazrat Abolfazl Hospitals, Gonabad and Kashmar, 2025–2026: A Triple-Blind Randomized Clinical Trial”

Effect of jujuba Lotion on Episiotomy Pain and Healing

Participants were randomized 1:1 via permuted blocks of four by an independent statistician. Allocation was concealed using sequentially numbered, opaque sealed envelopes. Sample size was estimated in G*Power 3.1.9.2 using an independent t-test (α=0.05, power=0.80); with 25% attrition, 42 participants per group were planned

After ethical approval and IRCT registration, the study was conducted at Allameh Bohlol and Hazrat Abolfazl hospitals. Participants were recruited by convenience sampling, gave informed consent, completed questionnaires privately, received standard perineal care, and underwent a skin patch test (0.1 mL lotion on the inner forearm). Absence of erythema, pruritus, or burning after 2 h was required to proceed

Inclusion: Females 18–45; primiparous/multiparous; 37–42 weeks gestation; singleton (neonate 2500–4000g); BMI 18.5–29.9; mediolateral episiotomy; hospitalization <24h; informed consent.Exclusion: Jujube allergy; perineal/genital infection; systemic diseases (e.g., diabetes, autoimmune, severe anemia); use of corticosteroids, immunosuppressants, anticoagulants, NSAIDs, zinc/vitamin E, or other topicals; complicated delivery (e.g., tears, hematoma, instrumental); rapid labor (<3h); psychiatric history; blood transfusion; ruptured membranes >24h; withdrawal.

Prior to the intervention, all participants received standardized perineal care instructions, and a skin sensitivity patch test (on the forearm for 2 hours) was performed to ensure the safety of the jujube fruit lotion

Episiotomy wound healing and pain relif

A random allocation sequence for assigning participants to the intervention and control groups will be generated by an independent statistician (data analyst) using permuted blocks of four. Allocation codes will be placed in sequentially numbered, opaque, sealed envelopes and will be opened by the researcher only at the time of participant enrollment. Therefore, the researcher will remain unaware of the assigned group until the moment of allocation, ensuring allocation concealment.

This study is designed as a triple-blind randomized controlled trial. Participants, the intervention researcher, the outcome assessor, and the statistical analyst will all be blinded to the type of intervention. The lotions (containing Ziziphus jujuba fruit extract and placebo) were prepared to be identical in color, scent, consistency, and packaging, and will be coded uniquely. Data will be entered into the statistical software in a coded format, and the codes will remain confidential until the end of the analysis. The intervention group will receive standard hospital care plus the Ziziphus jujuba fruit lotion. The control group will receive standard hospital care and the base lotion (placebo). The placebo consists of a base lotion without the Ziziphus jujuba extract, which has been standardized to match the appearance of the active lotion.

The complete clinical trial dataset, including all variables related to pain intensity and episiotomy wound healing in both the intervention and control groups. All direct and indirect personal identifiers will be removed, and the data will be fully de-identified to protect participants’ privacy. The codebook and variable guide, including definitions of all variables, measurement scales, and coding instructions to facilitate reproducibility of the analyses. The study protocol and data collection instruments, including the final approved protocol, questionnaires, and checklists used to assess wound healing and pain intensity. The statistical analysis files (syntax/scripts), including the codes used in statistical software for data cleaning, management, and analysis, allowing other researchers to reproduce the results.

Access to the study data and documentation will be granted starting 6 months post-publication

Data and documentation will be available upon request to qualified researchers and institutions

Research Purpose: Data must be used strictly for non-commercial, ethical scientific research. Security & Privacy: Users must not attempt to re-identify participants or transfer the data to third parties. Acknowledgment: Any publication or output resulting from these data must formally cite the original study and its investigators. Compliance: The request must include a defined analysis plan and confirmation of ethical alignment with the study’s original scope.

The Principal Investigator is responsible for reviewing and responding to all scientific requests. Applicants are required to submit their formal request, including the research project title and a brief description of the study’s objectives, to the following email address: Email: akbari.s.stu@gmu.ac.ir Subject Line: Data Request: Effect of Jujube Lotion on Episiotomy Healing 2. Secondary Contact: Clinical Research Development Office If you do not receive a response within 15 working days, you may forward your request to the Clinical Research Development Office at Gonabad University of Medical Sciences: Mailing Address: Clinical Research Development Office, Vice-Chancellery for Research and Technology, Gonabad University of Medical Sciences, Gonabad, Iran. Phone: +98 51 5722 3028

Applicants are required to submit a formal written request to the Principal Investigator via email, including their full name, institutional affiliation, contact information, the specific study title, and a brief description of the intended purpose of the requested data or documentation. All requests will be reviewed by the research team to ensure alignment with the study’s objectives and ethical requirements. If necessary, the applicant may be requested to provide supplementary information, such as a detailed analysis plan or proof of institutional ethical approval. Upon final approval, the specific terms of data usage will be communicated, and the documents or de-identified data files will be shared via secure channels. Regarding the timeline, the initial review process typically takes 5–7 working days. If additional clarification is required, further communication may take up to 5 working days, and the final preparation and release of the materials usually require 10–15 working days following final approval. Consequently, the entire process is estimated to be completed within 2 to 4 weeks, depending on the completeness of the initial request and the scope of the required review.