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IRCT20190625044009N2 IRCT 2024-04-19 Tehran University of Medical Sciences The effectiveness of ear acupressure on constipation and quality of life in pregnancy Determining the effect of ear acupressure on the severity and occurrence of constipation and related quality of life during the pregnancy: A Double-Blind, Randomized Controlled Trial 2024-05-04 anticipated 144 Complete https://irct.ir/trial/67469 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomized block design with a size of 4 was used for randomization. A total number of 36 blocks of four were prepared. Then, the samples were assigned to intervention and control groups. A specific letter is assigned to each group to construct the allocation sequence (A: Intervention Group, B: control Group). The allocation sequence will then be generated using online methods (https://www.sealedenvelope.com/simple-randomiser/v1/lists) without individual intervention. Next, the sequence is written on the sheets and placed in sealed envelopes, respectively to conceal the allocation sequence, Blinding description: The random sequence will be provided to the main researcher and then based on the created sequence; each participant will be assigned to a particular group. Then, they will be placed in envelopes designed for this purpose, and each envelope will be numbered and closed. The person who is responsible for the implementation of the study will open the envelopes based on the number assigned to the patients and will perform the intervention based on the respective group. The person who is responsible for conducting the study is unaware of the type of intervention in the control and intervention groups. Since this intervention is performed in sham points for the control group, the patients are not informed of the nature of the allocated group. N/A Constipation in pregnancy. Intervention 1: Intervention group: Both external earlobes are first cleaned with 75% alcohol, then the points of the rectum, large intestine, spleen, Shen Men and Senjia are determined and a magnetic seed is placed by the researcher in each point. Then the researcher teaches the patients to press the seeds 8 times a day for one minute each time. Pressing the points should be continued until they feel tingling or slight discomfort hese seeds remain in the constipation control points for 7 days and then removed. Intervention 2: Control group: Both external earlobes are first cleaned with 75% alcohol; then, the points of vision, knee joint, eye, and shoulder joint (which do not have any effect on constipation) are determined. A magnetic seed is placed by the researcher in each point. Then, the researcher teaches the patients to press the seeds 8 times a day for one minute each time. Pressing should be continued until they feel tingling or slight discomfort. These seeds should remain in the constipation control points for 7 days and then removed. No - There is not a plan to make this available Justification or reason for not sharing IPD is Currently, no decision has been made in this regard by the team
public Mahla Rajabzadeh
School of Nursing and Midwifery, Torbat Heydarieh University of Medical Sciences, Razi St., Torbat Heydarieh
Torbat Heydariyeh Iran (Islamic Republic of) 9519633787 +98 51 5222 9202 rajabzadehm951@gmail.com Torbate-Heidaria University of Medical Sciences scientific Mahla Rajabzadeh
School of Nursing and Midwifery, Torbat Heydarieh University of Medical Sciences, Razi St., Torbat Heydarieh
Torbat Heydariyeh Iran (Islamic Republic of) 9519633787 +98 51 5222 9202 rajabzadehm951@gmail.com Torbate-Heidaria University of Medical Sciences Iran (Islamic Republic of) Pregnant women aged 18-35 years at any gestational age A singleton pregnancy with a normal and live embryo Wanted pregnancy Pregnancy constipation background based on the ROME III index Literacy No record of chronic constipation and digestive disorders, such as irritable bowel syndrome, anal fissure, rectal prolapse, intestinal obstruction and skin disease No record of infection and local lesion in the ear area No recent use of pharmaceutical or non-pharmacological methods to reduce constipation Not record of active or passive smoking 18 years 35 years Female Suffering from chronic constipation, requiring medicine interventions (e.g., emollient, cassia, fig, hedge mustard, and Fusion herbal syrup) Digestive disorders, such as irritable bowel syndrome Psychological treatment history (medicine and mental treatment) K59.0 Constipation Treatment - Other Placebo Intervention group: Both external earlobes are first cleaned with 75% alcohol, then the points of the rectum, large intestine, spleen, Shen Men and Senjia are determined and a magnetic seed is placed by the researcher in each point. Then the researcher teaches the patients to press the seeds 8 times a day for one minute each time. Pressing the points should be continued until they feel tingling or slight discomfort hese seeds remain in the constipation control points for 7 days and then removed Control group: Both external earlobes are first cleaned with 75% alcohol; then, the points of vision, knee joint, eye, and shoulder joint (which do not have any effect on constipation) are determined. A magnetic seed is placed by the researcher in each point. Then, the researcher teaches the patients to press the seeds 8 times a day for one minute each time. Pressing should be continued until they feel tingling or slight discomfort. These seeds should remain in the constipation control points for 7 days and then removed. Severity and occurence of Constipation. Timepoint: At the beginning of the study (before the intervention) and 7 days after the intervention. Method of measurement: Using the Constipation Assessment Scale for Pregnancy. Stool form. Timepoint: Before the intervention and during the intervention after each round of defecation is recorded. Method of measurement: Using the bristol stool form scale. Constipation quality of life. Timepoint: At the beginning of the study (before the intervention) and 7 days after the intervention. Method of measurement: Using the Constipation Quality of Life Scale. Vice chancellor for research, Tehran University of Medical Sciences Approved 2023-04-10 Ethics committee of Tehran University of Medical Sciences Room 604, 6th floor, central building of Tehran University of Medical Sciences, intersection of Qods St., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)