Sampling and participants
anorectal obstruction/blockage, constipation, spontaneous bowel movements, chronic constipation, Constipation
VIRUS, BLIND
In this study, significance level (0.05) and statistical power (0.9) were used to determine the sample size (ZMale participants were divided into two groups by simple and stratified random sampling by blind statistician. At first, male participants were selected by the researcher and coded and classified based on the severity of the symptoms of constipation and laxative use, and then stratified by the statistician who was blind to the participants. Through the production of random numbers, the participants were divided into two groups of intervention and control by simple randomization. Due to the lack of concurrent access to all women in the research community, because of the spread of the corona virus and the quarantine of some women's RCH, they were divided into two groups at consecutive time intervals based on a computer-generated 4-block random sequence (with R software) which was created by the statistician (an example of two block sequences: "BABA" "ABBA"). After completion of randomization, the intervention was performed without delay. In this study, the participants and the statistician who was responsible for random allocation and data analysis were blinded to the participants’ group assignments. Participants were blind to group assignment, and in both groups, auricular plasters with the similar appearance were used. Thus, the participants were not informed about the differences (seeds and stimulation) in the intervention. The researcher implementing the intervention (care provider) was not blinded.Seventy-six older people suffering from constipation were identified according to the medical records and daily reports, and chronic constipation was confirmed by Rome IV diagnostic criteria. Then, among the eligible older people who understood the purpose of the study and agreed to participate (more than 95% of eligible participants consented to participate and three people refused to give consent), 30 people were selected for the intervention group and 30 people for the control group. Inclusion criteria included: (1) age between 65–85, (2) Constipation according to the diagnostic criteria of Rome IV; must have more than 2 of the following criteria during at least the past 3 months with onset of symptoms at least 6 months ago (for > 25% of defecations): straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage, manual maneuvers to facilitate defecation, less than three spontaneous bowel movements per week [