Viewing Study NCT04935723



Ignite Creation Date: 2024-05-06 @ 4:17 PM
Last Modification Date: 2024-10-26 @ 2:07 PM
Study NCT ID: NCT04935723
Status: COMPLETED
Last Update Posted: 2022-03-10
First Post: 2021-06-10

Brief Title: The Effects of Reiki on Abdominal Surgery Patients Anxiety Fear Postoperative Pain and Life Findings
Sponsor: Cukurova University
Organization: Cukurova University

Study Overview

Official Title: Cukurova University
Status: COMPLETED
Status Verified Date: 2022-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Abdominal surgeries are those in which pain is felt severely due to the incision close to the diaphragm and an intensive neural network in the abdominal area If the patients post-operative pain is not controlled Since it will restrict patient mobility it can cause problems on many systems such as the pulmonary cardiovascular and neuroendocrine system and even suppress the immune system Surgical intervention decision can cause anxiety in individuals regardless of the type of surgical procedure Fear of anesthesia fear of death possibility of developing complications after surgery pain change in daily life activities loss of social life and loss of control can lead to anxiety In addition to all these factors such as pain fear anxiety that stimulate the sympathetic nervous system can increase the pulse rate blood pressure and respiratory rate

Reiki a complementary and alternative medicine TAT method is a bioenergy based on the energy use of the body and has been used in various cultures for centuries in preventing and treating some diseases Reiki is thought to help balance the bodys natural energetic systems and reduce anxiety by transferring the available energy through hands During Reiki the activity of the parasympathetic system increases pain and anxiety decrease Thus the patients complaints are reduced by providing early discharge with possible complications after surgery

Studies on the effectiveness of reiki which is increasing worldwide use and recommended as a treatment approach for health services are insufficient The aim of this study which is planned as a three-group interventional randomized control is to examine the effect of reiki application on patients negative reflections on pain anxiety fear and vital signs which is the major surgery type in which patients experience the most pain
Detailed Description: In line with the results of the power analysis using the Gpower 3192 program it was planned to include 31 patients in reiki 31 patients in sham reiki and 31 patients in the control group and the simple randomization method was used to distribute the sample to the study groups Research data were collected in a quiet single room in the operating room Pre-op Unit and in the patient rooms of General Surgery I and II Clinics between July 2020 and December 2020 In order to determine the clarity of the data collection form after obtaining permission from the ethics committee and pre-application with 12 patients who met the study criteria Personal Information Form Patient Follow-up Form and Postoperative Period Patient Analgesic Follow-up Form and Reiki-Related Feedback Form were prepared filled Application Data were collected before and after reiki in the Pre-op unit on the 0th day before the operation and in the General Surgery I and II clinics on the 1st and 2nd days after the operation After obtaining the consent of the patient in the preoperative unit the Personal Information Form the Surgical Fear Scale and the STAI-I State Anxiety Scale were applied and the results and vital findings after SPO2 were recorded in the Patient Follow-up Form According to randomization the patients in the reikisham reiki group were taken to a quiet single room and reikisham reiki was applied for approximately 25-30 minutes Done Reiki application was applied by a researcher who received Reiki II level training and sham reiki was applied by a health professional who did not receive reiki training A written protocol is provided to both the Reiki practitioner and Sham Reiki practitioner describing hand positions areas of practice sequence and times 5 minutes after the end of the application the Surgical Fear Scale and the STAI-I State Anxiety Scale were re-administered the patients SPO2 and vital signs were taken again In the control group according to randomization The Surgical Fear Scale and the STAI-I State Anxiety Scale were applied and the patients vital signs and SPO2 were measured 30 minutes from assessment Then all measurements were repeated and recorded on the Patient Follow-up Form

On the 1st and 2nd postoperative days 4 hours after the routine analgesic drug administration pulse respiratory rate blood pressure and SPO2 were measured and recorded in the patient follow-up form After assessing the severity of pain with the Visual Comparison Scale and the anxiety with the STAI-I State Anxiety Inventory the patient was evaluated once a day for 25-30 minutes depending on the group he was in minute reikisham reiki was applied 5 minutes after the end of the application Then the patients pulse respiratory rate blood pressure and SPO2 were measured again and recorded in the Patient Follow-up Form The severity of pain was re-evaluated with the Visual Comparison Scale and the state anxiety level with the STAI-I State Anxiety Inventory The analgesic dosesnumbers used on the 1st and 2nd days were recorded in the Analgesic Usage Follow-up Form Routine postoperative care was given to the control group without any intervention and data collection tools were applied at the same time as the experimental group twice at 30-minute intervals After the final evaluation on the 2nd day Reiki and Sham Reiki were applied to the group and the Reiki Application Feedback Form was applied

Statistical analyzes were performed using a package program called SPSS IBM SPSS Statistics 24 Frequency tables and descriptive statistics were used to interpret the findings Parametric methods were used for measurement values suitable for normal distribution The Independent Sample-t test t-table value was used and the ANOVA test F-table value method was used to compare the measurement values of two independent groups in accordance with parametric methods Compare the measurement values of three or more independent groups The Paired Sample-t test t-table value method was used to compare the measurement values of the two dependent groups Non-parametric methods were used for the measurement values that did not fit the normal distribution Mann-Whitney U test Z-table value and Kruskal-Wallis H test χ2-table value were used to compare the measured values of two independent groups in accordance with non-parametric methods method was used to compare the measurement values of three or more independent groups The Wilcoxon test Z-table value method was used to compare the measurement values of the two dependent groups

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None