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IRCT20230723058896N1 IRCT 2023-09-09 Oroumia University of Medical Sciences Comparing the effect of GUIDED IMAGERY and CRYOTHERAPY(cold compress) on post operative pain severity and vital signs among laparoscopic cholecystectomy inpatients in Teaching Hospitals - Comparing the effect of GUIDED IMAGERY and CRYOTHERAPY(cold compress) on post operative pain severity and vital signs among laparoscopic cholecystectomy inpatients in Teaching Hospitals 2023-09-11 anticipated 93 Complete https://irct.ir/trial/71841 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Simple randomization The current study is a randomized controlled and one-sided blind trial with a sample size of 93 people in the form of three groups, 31 people in the guided imaging group with code one, 31 people in the cryotherapy group with code two, and 31 people in the control group with code three. In order to randomize, in a simple way, numbers from one to three are written on 93 sheets, and applicants who meet the entry criteria are asked to choose one of the numbers from one to three, and by choosing each number, the said number from It goes out between the sheets, Blinding description: The present study is a one blind study with a sample size of 93 people divided into three groups, 31 people in the guided imaging group with code one, 31 people in the cryotherapy group with code two, and 31 people in the control group with code three. In order to randomize, in a simple way, numbers one to three are written on 93 sheets, and applicants who meet the entry criteria are asked to choose one of the sheets , and by choosing each number, the said number is selected from among the sheets. It should be noted that none of the clients have any knowledge about the allocation of codes 1, 2 and 3 to the intervention and control groups and are completely blinded. N/A Laparoscopic cholecystectomy. Intervention 1: Intervention group: In order to guided imagery , 20-minute voices or images will be used for this purpose under the supervision of a specialist consultant, according to the person's preference, which includes the sounds of the forest, sea, birds, fire and wind. Seekers in a calm and quiet environment. Voices or images. will receive through hands-free and pain intensity through the visual questionnaire of pain intensity (VAS) and vital signs by SAADAT brand portable monitor (calibrated and identical device) and to control the body temperature from the forehead area by infrared digital thermometer made in China The SK-30 INFRARED THERMOMETER model will be used and will be measured in 15-30-45-60 minutes. In addition to the mentioned times, we also measure the starting time (zero) of pain severity. Intervention 2: Intervention group: Patients receive cold therapy in the form of a cold compress in the temperature range of 15-18 degrees Celsius around the laparoscopic site for 20 minutes on a dressing that acts as a barrier to prevent direct contact and non-deep pressure, under the supervision of a specialist consultant, and in minutes 15-30-45-60 pain intensity is measured by (VAS) and vital signs by portable monitor and temperature by digital infrared thermometer. In addition to the mentioned times, we also measure the starting time (zero) of pain severity. Intervention 3: Control group: No intervention will be done in the control group.The intensity of pain in the patient after entering the department is measured 5 times - once immediately after entering the department and then in 15-30-45-60 minutes and vital signs are measured in 15-30-45-60 minutes and the collected data Demographic information will be recorded in the form for review and comparison. It should be noted that the client will receive treatment measures and painkillers if needed and with the order of the attending physician. The type and dose of painkillers received will be recorded in the demographic information form for review and comparison. During the entire study, the researcher will be present with all the patients of all three groups. 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 Shasaddin Shamsi
Urmia Nursing-Midwifery Faculty
Urmia Iran (Islamic Republic of) 5756115335 +98 44 3275 4961 shamsi_sh@umsu.ac.ir Oroumia University of Medical Sciences scientific Shamsaddin Shamsi
Urmia Nursing-Midwifery Faculty
Urmia Iran (Islamic Republic of) 5756115335 +98 44 3275 4961 shamsi_sh@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Candidate for laparoscopic cholecystectomy surgery Satisfaction and willingness to participate in the research Age between 20-60 years old Alertness after the operation the disappearance of the effects of anesthetic drugs before the start of the intervention Ability to use numerical scale of pain intensity Having pain with a score greater than 3 No impairment in speech, hearing, vision and communication Ability to speak Persian or Turkish Do not have heart surgery or any cardiovascular disorder Do not have a disease related to the prohibition of the use of cold, such as Raynaud's syndrome No history of nerve diseases (neuropathy, muscle stiffness and poor blood circulation) Any confirmed mental illness 20 years 60 years Both Unwillingness to participate and continue studying Occurrence of physical problems and inability to continue the plan Discharge of the patient by personal consent or death of the patient Performing any procedure outside the routine schedule Use of PCA pump K80.01 Calculus of gallbladder with acute cholecystitis with obstruction Rehabilitation Prevention N/A Intervention group: In order to guided imagery , 20-minute voices or images will be used for this purpose under the supervision of a specialist consultant, according to the person's preference, which includes the sounds of the forest, sea, birds, fire and wind. Seekers in a calm and quiet environment. Voices or images. will receive through hands-free and pain intensity through the visual questionnaire of pain intensity (VAS) and vital signs by SAADAT brand portable monitor (calibrated and identical device) and to control the body temperature from the forehead area by infrared digital thermometer made in China The SK-30 INFRARED THERMOMETER model will be used and will be measured in 15-30-45-60 minutes. In addition to the mentioned times, we also measure the starting time (zero) of pain severity Intervention group: Patients receive cold therapy in the form of a cold compress in the temperature range of 15-18 degrees Celsius around the laparoscopic site for 20 minutes on a dressing that acts as a barrier to prevent direct contact and non-deep pressure, under the supervision of a specialist consultant, and in minutes 15-30-45-60 pain intensity is measured by (VAS) and vital signs by portable monitor and temperature by digital infrared thermometer. In addition to the mentioned times, we also measure the starting time (zero) of pain severity Control group: No intervention will be done in the control group.The intensity of pain in the patient after entering the department is measured 5 times - once immediately after entering the department and then in 15-30-45-60 minutes and vital signs are measured in 15-30-45-60 minutes and the collected data Demographic information will be recorded in the form for review and comparison. It should be noted that the client will receive treatment measures and painkillers if needed and with the order of the attending physician. The type and dose of painkillers received will be recorded in the demographic information form for review and comparison. During the entire study, the researcher will be present with all the patients of all three groups. Pain severity. Timepoint: Before the start of the intervention (zero time) - 15-30-45-60 minutes. Method of measurement: Visual analogue scale questionnaire. Vital signs. Timepoint: 15-30-45-60 minutes. Method of measurement: Portable monitoring device and thermometer. Oroumia University of Medical Sciences Approved 2023-02-01 ethics committee of urmia medical university of science Research and Technology Vice-Chancellor, Building No. 10, West Azerbaijan University of Medical Sciences and Health Services, Jihad St., Resalat Blvd. Urmia West Azarbaijan Iran (Islamic Republic of)