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IRCT20210310050657N1 IRCT 2021-12-01 Rafsanjan University of Medical Sciences The Effect of Acupressure on Abortion The Investigation of the effect of acupressure on pain intensity and anxiety in hospitalized women in Niknafs maternity hospital in Rafsanjan, 2020 2021-11-21 anticipated 120 Complete https://irct.ir/trial/55965 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Sampling will be done by randomly minimization method, based on the pre-test pain score classes (i.e., severe and moderate). Randomization units will be entered into the study individually. The first sample will be allocated to each class in one of the study groups by random lottery through the sealed envelope. The arrival of the next sample with the same pre-test pain class between the two remaining groups will also be done by lottery. The third sample with the same attribute will be assigned to the last group in the same category. This process will continue until the desired sample size is reached. It is noteworthy that the samples will not be aware of how they will be assigned into the groups, Blinding description: In this double-blind study, only acupressure specialist is aware of the allocation of samples. Samples and questioners will be unaware of samples’ allocation in the groups. The questioner will fill in the questionnaire and is unaware of the allocation of samples in groups. Then, the acupressure expert will randomly place the samples in intervention, touch, and control groups and perform specific actions for each group. It is of note that the patients are also unaware of the group they belong to. N/A Abortion. Intervention 1: Intervention group: Acupressure at LI4 point (in middle of the angle between the first and second bones of the palm between the thumb and index finger on the back of the hand) bilaterally in periods of 10 seconds of pressure and 2 seconds of rest, for 20 minutes in a row It is applied to the extent that the specimens have a feeling of warmth and mild pain and pressure. Intervention 2: Touch group: For the touch group, non-pressure touch will be performed at LI4 point similar to the intervention group and with the same times, in 20 minutes. Intervention 3: Control group: For the control group, they will not receive any intervention other than routine ward care (taking a vein, requesting CBC, connecting Ringer's serum at the time of starting bleeding ). The questionnaire will be filled in at 0, 20 and 50 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is No information available
public Zohreh Sahebi Sham Abadi
NO38, Northern Meraj 40. Bahonar Blvd
Rafsanjan Iran (Islamic Republic of) 7719678375 +98 34 3423 0559 sahebizm@rums.ac.ir Rafsanjan University of Medical Sciences scientific Zohreh Sahebi Sham Abadi
NO38, Northern Meraj 40. Bahonar Blvd
Rafsanjan Iran (Islamic Republic of) 7719678375 +98 34 3423 0559 sahebizm@rums.ac.ir Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 45 years Hospitalization with a diagnosis of spontaneous or induced abortion Having a pain score higher than 3 based on the VAS scale Single pregnancy Gestational age less than 20 weeks based on LMP or ultrasound No lesions at the site of acupressure Having enough cognitive power to answer research questions No drug and alcohol abuse No history of known mental illness 18 years 45 years Female Cases of severe bleeding at admission Taking any sedative before entering the study septic abortion cases O02.1 Missed abortion Other Other Placebo Intervention group: Acupressure at LI4 point (in middle of the angle between the first and second bones of the palm between the thumb and index finger on the back of the hand) bilaterally in periods of 10 seconds of pressure and 2 seconds of rest, for 20 minutes in a row It is applied to the extent that the specimens have a feeling of warmth and mild pain and pressure. Touch group: For the touch group, non-pressure touch will be performed at LI4 point similar to the intervention group and with the same times, in 20 minutes Control group: For the control group, they will not receive any intervention other than routine ward care (taking a vein, requesting CBC, connecting Ringer's serum at the time of starting bleeding ). The questionnaire will be filled in at 0, 20 and 50 minutes. Pain during abortion. Timepoint: Measurement of previous pain, immediately after and 30 minutes after the intervention. Method of measurement: The data collection tool will consist of three parts. The first part contains the demographic information questionnaire, the second part contains the 10-point visual instrument for measuring pain (VAS). The third part includes the Spielberger Anxiety Standard Questionnaire. Anxiety. Timepoint: Before the commence of intervention, immediately after the intervention and 30 minutes after the finishing of intervention. Method of measurement: Spielberger Anxiety Standard Questionnaire. Vice Chancellor of Research and Technology of Rafsanjan University of Medical Sciences Approved 2020-09-14 Ethics Committee of Rafsanjan University of Medical Sciences NO38, Northern Meraj 40. Bahonar Blvd Rَََafsanjan Kerman Iran (Islamic Republic of)