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IRCT20170313033047N3 IRCT 2023-06-18 Shahed University The effect of abdominal Thermotherapy on constipation and painful defecation The effect of abdominal Thermotherapy on constipation and painful defecation in hospitalized elderly 2023-06-14 anticipated 90 Complete https://irct.ir/trial/69358 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation by random block method (blocks of four). Blocking is usually used in order to create a balance in the number of samples assigned to each of the studied groups. This feature helps the researchers to ensure that the number of samples allocated to each of the studied groups is equal in cases where intermediate analyzes are needed during the sampling process. The samples are assigned to intervention and control groups by blocking randomization method with blocks of 4. Block randomization is used in an online generator: "https://www.sealedenvelope.com/simple-randomiser/v1/lists". To conceal the allocation, each of the randomly created sequences is written on a card and placed in an opaque and sealed envelope. At the time of registration of the participants, based on the order of entry of the eligible participants, the envelopes will be opened in order and the assigned group of the participant will be determined. N/A constipation. Intervention 1: Intervention group: Routine intervention for constipation will be performed for all patients based on the physician's order. For the intervention group, two times of heat therapy and each time, two times of heat therapy 60-90 minutes after having lunch and evening meal (according to the hospital routine) with a hot water bag in which water is poured and then the hot water bag putting in the water for 60 to 90 Celsius and when they are heated, it is wrapped in a towel that reaches a temperature of 50 Celsius, the temperature of which is controlled by a thermometer, and the hot water bag will be placed on the abdomen, in the periumbilical area, for 23 minutes, and the intervention will take place in two days. Each patient will receive the hot water bag a total of 4 times. Meals will be the same for all patients (due to the private nature of the hospital, snacks will be given to patients and they will receive less food from outside) and have the same movement pattern. Intervention 2: Control group: For all patients, routine intervention for constipation will be performed based on physician's order. For the control group, a hot water bag with a temperature of 25 Celsius, which is determined by a thermometer, wrapped in a towel and placed on the abdomen of the patients in the periumbilical area, exactly with the schedule is similar to the intervention group. Meals will be the same for all patients (due to the private nature of the hospital, snacks will be given to patients and they will receive less food from outside) and have the same movement pattern. 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 This must be with the permission of the university
public Maryam Jadid-Milani
Nursing Faculty of Shahed University, Persian Gulf Highway (beginning of Tehran-Qom highway), Opposite to Holy Shrine of Imam Khomeini.Tehran
Tehran Iran (Islamic Republic of) 33191​18651 0098 21 6641 51212130 milani@shahed.ac.ir Shahed University scientific Maryam Jadid-Milani
Nursing Faculty of Shahed University, Persian Gulf Highway (beginning of Tehran-Qom highway), Opposite to Holy Shrine of Imam Khomeini, Tehran
Tehran Iran (Islamic Republic of) 33191​18651 +98 21 5121 2130 milani2000ir@yahoo.com Shahed University Iran (Islamic Republic of) Over 60 years Cognitive health with a score higher than 7 in Abbreviated Mental Test(AMTs) Hospitalization in the internal department due to internal and infectious diseases based on clinical and paraclinical findings with the diagnosis of a specialist and having constipation Movement pattern of relative bed rest (RBR) according to the physician's order written in the file Having a stable physiological state to answer questions 60 years no limit Both having any clinical conditions that doubt or limit the use of local heat therapy, based on physician's order. Having alcohol and drug addiction Having psychological disorders recorded in the file Having swelling, ulcers, scratches and redness in the abdomen Having history of abdominal and pelvic surgery Having gastrointestinal diseases and ulcers (from beginning to end) Taking drugs effective on bowel movements in the last two weeks K59.0 Constipation Treatment - Other Treatment - Other Intervention group: Routine intervention for constipation will be performed for all patients based on the physician's order. For the intervention group, two times of heat therapy and each time, two times of heat therapy 60-90 minutes after having lunch and evening meal (according to the hospital routine) with a hot water bag in which water is poured and then the hot water bag putting in the water for 60 to 90 Celsius and when they are heated, it is wrapped in a towel that reaches a temperature of 50 Celsius, the temperature of which is controlled by a thermometer, and the hot water bag will be placed on the abdomen, in the periumbilical area, for 23 minutes, and the intervention will take place in two days. Each patient will receive the hot water bag a total of 4 times. Meals will be the same for all patients (due to the private nature of the hospital, snacks will be given to patients and they will receive less food from outside) and have the same movement pattern. Control group: For all patients, routine intervention for constipation will be performed based on physician's order. For the control group, a hot water bag with a temperature of 25 Celsius, which is determined by a thermometer, wrapped in a towel and placed on the abdomen of the patients in the periumbilical area, exactly with the schedule is similar to the intervention group. Meals will be the same for all patients (due to the private nature of the hospital, snacks will be given to patients and they will receive less food from outside) and have the same movement pattern. Changing the pattern of defecation. Timepoint: Before the intervention, the first and second days of the intervention. Method of measurement: Bristol stool scale. Change in pain during defecation. Timepoint: Before the intervention, the first and second days of the intervention. Method of measurement: Numerical scale for pain intensity measurement. Shahed University Approved 2024-02-27 Ethics committee of Shahed University Shahed University, Persian Gulf Highway (beginning of Tehran-Qom highway), Opposite to Holy Shrine of Imam Khomeini Tehran Tehran Iran (Islamic Republic of)