Investigating the effect of Valeriana Officinalis Capsule on postpartum pain

Determining the effect of valerian capsules on the severity of postpartum pain

Randomized controlled clinical trial with parallel groups, triple blind, phase 3 on 70 primiparous women. Randomization will be done using Excel software with the function of random numbers.

This study will be conducted in the field of postpartum care in the Mahdieh Hospital, Tehran.The sample size includes 70 primiporous women who will be randomly divided into two groups. For all research units, the questionnaire of personal and demographic information is completed and the checklist for assessing the severity of back pain is completed before the start of intervention. The study is triple-blinded (the samples, researchers and analysts are unaware of which person is receiving the drug or the placebo).After the intervention, the two groups will be evaluated and compared to the severity of back pain

Inclusion criteria:Iranian women, married, vaginal delivery, baby weight between 2500 and 4000 grams, women with moderate to severe back pain, speaking Persian, primiparous, age between 18 and 35 years old. Exclusion criteria: occurrence of complications after childbirth, including bleeding, fever and high blood pressure 90/14

Intervention group:2 hours after delivery, every 8 hours for 24 hours, one valeriana capsule containing 500 mg of drug powder is given. Control group:2 hours after delivery,a placebo capsule containing 500 mg of starch is given every 8 hours for 24 hours. This capsule will be prepared in the school of Pharmacy of Shahid Beheshti.

Severity of postpartum pain

Random assignment to intervention and control groups: ​The function of random numbers will be used to randomize and assign people to groups. Randomization will be done using Excel software and the list of random numbers will be the total number of samples, which will be recorded in front of each drug code number A or B. Before starting the study, the capsules will be placed in similar envelopes by the drug consultant, and code A or B will be recorded on each envelope. 4 capsules will be placed in each envelope.There are 4 medicine capsules in one envelope and 4 placebo capsules in the next envelope. after the start of the study, based on the list of random numbers and specified groups, the envelopes of medicines will be provided by the researcher to the research units in the order of entry into the study. Mefenamic acid routine treatment will be given to both groups.

When preparing medicine and placebo, the pharmacist gives a code of one or two to their cans, and the code will remain hidden for the researcher, research unit and data analyst until the end of the analysis.