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IRCT20200411047017N1 IRCT 2020-07-19 Esfahan University of Medical Sciences Comparison of the effect of two methods of family visits and acupressure on nausea and vomiting and some physiological indicators after laparoscopic cholecystectomy in the post-anesthesia care unit Comparison of the effect of two methods of family visits and acupressure on nausea and vomiting and some physiological indicators after laparoscopic cholecystectomy in the post-anesthesia care unit. 2020-06-06 anticipated 105 Complete https://irct.ir/trial/47045 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to create a balance in the number of samples allocated to each of the studied group, block randomization method will be used and the size of each block will be 3. A reputable website (https://www.sealedenvelope.com/simple-randomiser/v1/lists) is used to randomly assign random blocks, then the samples are placed in each of the intervention or control groups, Blinding description: In order to perform blindness in this study, information will be collected by a research colleague who, to ensure the correct performance of the colleague, the information for 5 patients is randomly recorded by the researcher and research colleague and then compared with each other. Blindness will also be considered for data analysis. N/A Condition 1: cholecystitis. Condition 2: postoperative nausea and vomiting. Intervention 1: Intervention Group 1, which visits the family, explains to the patient that after surgery and in recovery, a first-degree relative will be present at his or her bedside and asked to express the name of a person who feels most comfortable with him or her . The visitor is then assessed separately and their abilities to participate in the study are assessed. People under the age of 18 and those who are scared and anxious when they see monitors and equipment next to the patient are not suitable to participate in the study. After confirming the accompanying ability to participate in the study, the etiquette of meeting in recovery is explained to them. If the researcher finds that the patient does not understand the explanation with the questions and answers while teaching, the sample will be removed from the study. This training will be face-to-face and will be done by the researcher and the companion will be asked to control their nerves, give all their focus to their patient, face the patient with a determined spirit, Touch his head, face or hands and comfort him. Then, visitor enters recovery after put on the surgical gown and shoes and washing his hands. In order to protect the privacy of other patients, partitions around the sample's bed will be placed. The visitor will stay with the patient for 7 to 10 minutes with the permission of the person in charge of the recovery department. This intervention will be done in addition to routine recovery care, including warming the patient, oxygen therapy, fluid therapy, pain relief, vital signs check, surgical wound and drainage control, and controlling nausea and vomiting, and more. In the case of severe nausea and vomiting, patients will take medications(Ondansetron) , according to doctor's diagnosis. Intervention 2: For the intervention group 2, which is acupressure, the researcher will be trained before the intervention under the supervision of a specialist in acupressure. Pressure will be applied to each of the P6 and LI4 points with the thumb for 2 to 5 minutes to apply pressure, so that pressure is applied for 10 seconds and stopped for 2 seconds. The intensity of the pressure would be such that one third of the thumbnails turn white and the pressure is applied rotational in a clockwise direction. The intensity of the pressure should be optimal, firm and stable, and pleasant to the point of pain. It should be high enough for the person to feel mild pain, tingling, and numbness at that point. at first the pressure apply in point P6 and then LI4 to the left hand. This intervention will be done in addition to routine recovery care. In the case of severe nausea and vomiting, patients will take medications(Ondansetron), according to doctor's diagnosis. Intervention 3: In group 3, which is the control group, routine recovery proceedings include warming the patient, oxygen therapy, fluid therapy, pain relief, vital signs check, surgical wound and drainage control, will be done, And no intervention is done by the researcher. And to control nausea and vomiting, if patients in any of the three groups suffers from severe nausea and vomiting, medication (Ondansetron) will be taken by patients, according to doctor's diagnosis. 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 After collecting the sample, a decision will be made in consultation with the supervisor and the consulting professors.
public Fateme Zeraatpishe
Hezar-Jerib St, Isfahan University of Medical Science
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 7510 zeraatpishe@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Akram Aarabi
Hezar-Jerib St, Isfahan University of Medical Science
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 7510 aarabi@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for laparoscopic cholecystectomy Patients who are alert and aware of time and place Patients with age 18-65 18 years 65 years Both Patients who are candidate for emergency cholecystectomy laparoscopic Patients with a history of mental illness Patients with a specific digestive problem that leads to nausea and vomiting Patients with cardiovascular disease and hyperytension K80.0 R11 Calculus of gallbladder with acute cholecystitis Nausea and vomiting Other Other Other Intervention Group 1, which visits the family, explains to the patient that after surgery and in recovery, a first-degree relative will be present at his or her bedside and asked to express the name of a person who feels most comfortable with him or her . The visitor is then assessed separately and their abilities to participate in the study are assessed. People under the age of 18 and those who are scared and anxious when they see monitors and equipment next to the patient are not suitable to participate in the study. After confirming the accompanying ability to participate in the study, the etiquette of meeting in recovery is explained to them. If the researcher finds that the patient does not understand the explanation with the questions and answers while teaching, the sample will be removed from the study. This training will be face-to-face and will be done by the researcher and the companion will be asked to control their nerves, give all their focus to their patient, face the patient with a determined spirit, Touch his head, face or hands and comfort him. Then, visitor enters recovery after put on the surgical gown and shoes and washing his hands. In order to protect the privacy of other patients, partitions around the sample's bed will be placed. The visitor will stay with the patient for 7 to 10 minutes with the permission of the person in charge of the recovery department. This intervention will be done in addition to routine recovery care, including warming the patient, oxygen therapy, fluid therapy, pain relief, vital signs check, surgical wound and drainage control, and controlling nausea and vomiting, and more. In the case of severe nausea and vomiting, patients will take medications(Ondansetron) , according to doctor's diagnosis. For the intervention group 2, which is acupressure, the researcher will be trained before the intervention under the supervision of a specialist in acupressure. Pressure will be applied to each of the P6 and LI4 points with the thumb for 2 to 5 minutes to apply pressure, so that pressure is applied for 10 seconds and stopped for 2 seconds. The intensity of the pressure would be such that one third of the thumbnails turn white and the pressure is applied rotational in a clockwise direction. The intensity of the pressure should be optimal, firm and stable, and pleasant to the point of pain. It should be high enough for the person to feel mild pain, tingling, and numbness at that point. at first the pressure apply in point P6 and then LI4 to the left hand. This intervention will be done in addition to routine recovery care. In the case of severe nausea and vomiting, patients will take medications(Ondansetron), according to doctor's diagnosis. In group 3, which is the control group, routine recovery proceedings include warming the patient, oxygen therapy, fluid therapy, pain relief, vital signs check, surgical wound and drainage control, will be done, And no intervention is done by the researcher. And to control nausea and vomiting, if patients in any of the three groups suffers from severe nausea and vomiting, medication (Ondansetron) will be taken by patients, according to doctor's diagnosis. Average of blood pressure. Timepoint: Before induction of anesthesia, after the intervention, up to 12 hours in the surgical unit. Method of measurement: Monitoring system. Average oxygen saturation of arterial blood. Timepoint: Before induction of anesthesia, after the intervention, up to 12 hours in the surgical unit. Method of measurement: pulse oximeter probe. The average number of heartbeats. Timepoint: Before induction of anesthesia, after the intervention, up to 12 hours in the surgical unit. Method of measurement: Monitoring system. The average number of breaths. Timepoint: Before induction of anesthesia, after the intervention, up to 12 hours in the surgical unit. Method of measurement: Monitoring system. Average of patients pain intensity. Timepoint: Before and after the intervention. Method of measurement: Visual Analogue Scale. The average of vomiting number, severity and extent. Timepoint: Before induction of anesthesia, before leaving recovery, up to 12 hours in the surgical unit. Method of measurement: Rhodes questionnaire. The average score of the number, duration and severity of nausea. Timepoint: Before induction of anesthesia, before leaving recovery, up to 12 hours in the surgical unit. Method of measurement: Rhodes questionnaire and Visual Analog Scale. Esfahan University of Medical Sciences Approved 2020-04-20 Ethics Committee of Isfahan University of Medical Sciences Isfahan-Hezar Jerib St.-Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)