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IRCT20220815055712N1 IRCT 2023-01-14 Ghoum University of Medical Sciences The effect of auriculotherapy on sleep disorders among mothers in the postpartum period The effect of auriculotherapy on sleep disorders among mothers in the postpartum period 2022-11-21 anticipated 52 Complete https://irct.ir/trial/65358 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random assignment of participants in two control and intervention groups is done by random block method with a ratio of 1:1 and using blocks of 4. For this purpose, blocks of 4 are made with different combinations of two members A and B, and according to the sample size, a suitable number (13) of blocks are randomly selected and placed sequentially. The sequence obtained from the letters A and B will determine the entry of the participants into two groups, Blinding description: The participants are aware of the general introduction of the study groups and blinding is done with the aim that the participants are not aware of being in the intervention or control group. There are no differences in appearance between the work done for the intervention and control groups, and auriculotherapy is performed for both groups, with the only difference that, in the control group, the stickers without grains (which are similar in color and appearance to the adhesives with grains) It is placed on points unrelated to the purpose of the study, and only the researcher knows the difference between the groups. N/A Condition 1: sleep disorder. Condition 2: Anxiety. Intervention 1: Intervention group: In the intervention group, first, four points in both ears (Shen Man, Relaxation, etc.) are stimulated with a manual Pointer and then the seeds are glued. In such a way that if the vital signs are normal, the researcher sticks the tags containing Vacaria seed after disinfecting the ear with 70% alcohol in the mentioned points and teaches the research units to touch each point for one minute in four shifts (morning, noon, in the evening and at night) and press for 5 days (it is emphasized that the amount of pressure should be at a level that causes numbness, warmth or pain and burning sensation at that point). It is emphasized to the research units that after the completion of 5 days (8-10 days after delivery) they should return to the health center, again The new one is glued by the researcher and the second intervention is carried out for 5 days like the first intervention. Intervention 2: Control group: In the placebo group, simple labels (without vacaria seeds) that are similar in color and appearance are pasted in unrelated places, and all follow-ups and completion of questionnaires are the same as in the intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Fateme Sadat Mousavi
West Aast No 2., Moallem Blvd., Qom City
Qom Iran (Islamic Republic of) 3715835155 +98 25 3783 1370 mousavif.1990@gmail.com Ghoum University of Medical Sciences scientific Fateme Sadat Mousavi
West Aast No 2., Moallem Blvd., Qom City
Qom Iran (Islamic Republic of) 3715835155 +98 25 3783 1370 mousavif.1990@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) A written consent have to participate in the study Having an age range of 18 to 45 years Vaginal delivery of a healthy term singleton baby At least be literate in reading and writing 18 years 40 years Female The Pittsburgh Questionnaire score is lesser than five Have a history of using auriculotherapy. Presence of wound, infection, pain, or injury at the ear Taking anti-anxiety and sedative drugs Addicted to alcohol, tranquilizers and drugs The presence of medical disorders in the mother, such as heart, respiratory, liver or nerve diseases G47 Sleep disorders Treatment - Devices Treatment - Devices Intervention group: In the intervention group, first, four points in both ears (Shen Man, Relaxation, etc.) are stimulated with a manual Pointer and then the seeds are glued. In such a way that if the vital signs are normal, the researcher sticks the tags containing Vacaria seed after disinfecting the ear with 70% alcohol in the mentioned points and teaches the research units to touch each point for one minute in four shifts (morning, noon, in the evening and at night) and press for 5 days (it is emphasized that the amount of pressure should be at a level that causes numbness, warmth or pain and burning sensation at that point). It is emphasized to the research units that after the completion of 5 days (8-10 days after delivery) they should return to the health center, again The new one is glued by the researcher and the second intervention is carried out for 5 days like the first intervention. Control group: In the placebo group, simple labels (without vacaria seeds) that are similar in color and appearance are pasted in unrelated places, and all follow-ups and completion of questionnaires are the same as in the intervention group. The sleep quality score in the Pittsburgh Sleep Quality Questionnaire. Timepoint: The beginning of the study (before the intervention), 5 and 10 days after auriculotherapy. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Anxiety. Timepoint: فhe beginning of the study (before the start of the intervention), 5 and 10 days after auriculotherapy. Method of measurement: Spielberger anxiety questionnaire. Ghoum University of Medical Sciences Approved 2021-03-13 Ethics committee of Qom University of Medical Sciences West Aast No 2., Moallem Blvd., Qom City Qom Ghoum Iran (Islamic Republic of)