Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04935723 |
| Other study ID # |
G-5097-2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2020 |
| Est. completion date |
December 25, 2020 |
Study information
| Verified date |
March 2022 |
| Source |
Cukurova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 patient's
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 body's 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
patient's 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.
Description:
In line with the results of the power analysis using the Gpower 3.1.9.2 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 reiki/sham reiki group were
taken to a quiet single room and reiki/sham 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 patient's 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 patient's 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 reiki/sham
reiki was applied. 5 minutes after the end of the application. Then, the patient's 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
doses/numbers 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.
