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IRCT20151107024919N10 IRCT 2020-09-30 Kerman University of Medical Sciences effect of auricular acupressure on the constipation and that related quality of life among the elderlies in residential care home The Investigation of auricular acupressure effects on the constipation and that related quality of life among the elderlies in residential care home 2020-09-22 anticipated 50 Complete https://irct.ir/trial/51008 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to assign the participants to the intervention and control groups, the stratified randomization method is used, so we use the stratified randomization method based on the consumption of liquids, fruits and laxatives, and then a simple random assignment.first all participants are classified according to the collected information based on the consumption of liquids, fruits and laxatives and then we list and number the sample participants and using SPSS software, participants are randomly divided into two groups and Controls are divided.So that men and women are divided into groups separately; Then, in each group, men and women are used in a stratified random and simple random method, and half of the men are in the intervention group and the other half are in the control group (the same will be done for women), Blinding description: Participants are randomly assigned to one of the intervention and control groups by a statistician who is blind to the study and the data analyst does not know which data is related to the intervention group and which data is related to the control group. N/A constipation. Intervention 1: the intervention includes was applied to seven auricular acupoints for 10 days using vaccaria seeds for the intervention group. Thus, to apply constant pressure on the ear during the day and night, we use Vaccaria seeds at seven specific points on the ear, and the researcher gently presses the vaccaria seeds three to four times a day until the elderly feel a slight pain. First, we clean the marked points on the patient's ear with 70% alcohol, then to apply continuous pressure on the ear during the day and night, auricular plasters with vaccaria seeds (0.5 * 0.5 cm) are used on the marked points. After 5 days, auricular plasters with vaccaria seeds were directly removed and we attach new auricular plasters with vaccaria seeds on the other ear , so we will have two 5-day periods, each ear alternately under auricular acupressure. if auricular plasters with vaccaria seeds are removed from the ear earlier than five days, the elderly are asked to immediately inform until apply new auricular plasters with vaccaria seeds. HuanQiu brand auricular plasters with vaccaria seeds made in China are used for acupressure. Intervention 2: Control group: For the control group, participants in control group received only auricular plasters without vaccaria seeds for 10 days in seven auricular acupoints and only their receive usual daily care and no intervention will be made on them. 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 The researcher doesn't have any interest to share because of ethical issues. ( there​ is No further information)
public Batool Tirgari
Kerman University of Medical Sciences, Medical University Campus, Haft- Bagh- Alavi Highway, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 b_tirgari@kmu.ac.ir Kerman University of Medical Sciences scientific Batool Tirgari
Kerman University of Medical Sciences, Medical University Campus, Haft- Bagh- Alavi Highway, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 b_tirgari@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Patient age between 65_85 years Patient with constipation according to ROME IV diagnostic criteria The patient's cognitive status score according to the Abbreviated Mental Test is equal to or greater than 6 Possibility to participate in the project for 20 days Ability to speak and understand Persian 65 years 85 years Both who had local lesions/infection of the ears, or absence of ear Previous experience with auricular acupressure over the past year Doing a treatment program other than taking laxatives to relieve constipation Has had abdominal surgery for the past six months Suffering from Alzheimer's disease, dementia or delirium disorder according to the physician's diagnosis and inclusion in the medical record Suffering from a wide range of physical and mental diseases affecting the constipation variable according to the physician's diagnosis and inclusion in the medical record K59.0 Constipation Other Other the intervention includes was applied to seven auricular acupoints for 10 days using vaccaria seeds for the intervention group. Thus, to apply constant pressure on the ear during the day and night, we use Vaccaria seeds at seven specific points on the ear, and the researcher gently presses the vaccaria seeds three to four times a day until the elderly feel a slight pain. First, we clean the marked points on the patient's ear with 70% alcohol, then to apply continuous pressure on the ear during the day and night, auricular plasters with vaccaria seeds (0.5 * 0.5 cm) are used on the marked points. After 5 days, auricular plasters with vaccaria seeds were directly removed and we attach new auricular plasters with vaccaria seeds on the other ear , so we will have two 5-day periods, each ear alternately under auricular acupressure. if auricular plasters with vaccaria seeds are removed from the ear earlier than five days, the elderly are asked to immediately inform until apply new auricular plasters with vaccaria seeds. HuanQiu brand auricular plasters with vaccaria seeds made in China are used for acupressure. Control group: For the control group, participants in control group received only auricular plasters without vaccaria seeds for 10 days in seven auricular acupoints and only their receive usual daily care and no intervention will be made on them. Constipation. Timepoint: Constipation will be measured before the intervention and after the intervention and 10 days after the end of the intervention. Method of measurement: Patient Assessment of Constipation–symptoms questionnaire (PAC-SYM). Constipation related quality of life. Timepoint: constipation related quality of life will be measured before the intervention and after the intervention and 10 days after the end of the intervention. Method of measurement: Patient Assessment of Constipation–Quality of Life Questionnaire (PAC-QOL). Kerman University of Medical Sciences Approved 2020-09-07 Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran kerman Kerman Iran (Islamic Republic of)