Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05103163 |
| Other study ID # |
2020/2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 10, 2020 |
| Est. completion date |
September 25, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Inonu University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Reflexology practice is an effective method in pain control by stimulating the release of
endorphins. The study was conducted to determine the effect of foot reflexology applied to
patients undergoing abdominal surgery on pain, patient satisfaction and vital signs. The
study was conducted in a randomized controlled manner. The population of the study consisted
of adult patients who underwent abdominal surgery in a university hospital in Turkey. The
sample consisted of 156 patients with the indicated power analysis, including the analysis 78
experimental and 78 controls. Data were collected between October 2020 and May 2021 using
Personal Information Form, Numerical Pain Scale, Newcastle Nursing Care Satisfaction Scale
and Vital Signs Registration Form.
Description:
This study was conducted in a randomized controlled experimental setup. This research was
conducted in the general surgery clinic of a university hospital in Turkey between October
2020 and May 2021.
The universe of the research; consisted of 261 patients aged 18 years and over who underwent
abdominal surgery in the general surgery ward of a university hospital. The G Power 3.1.9.7
computer program was used to calculate the sample size. According to this program, it was
determined that a total of 156 patients, 78 patients in each group, should be reached, with
an effect size of 0.4, a margin of error of 0.04, a confidence interval of 0.95, and a
population representation power of 95%. 57 patients who did not meet the inclusion criteria
and 48 patients who did not volunteer to participate in the study were not included in the
sample.
Which of the patients included in the study would be in the experimental group and which
would be in the control group was made according to the randomization table determined by the
web-based random assignment software (RAY). There are two columns in the table as group 1 and
group 2. Which column would be in the experimental group and which would be in the control
group was determined by drawing lots. As a result of the draw, it was determined that group 1
would be in the control group and group 2 would be in the experimental group. Then, group
assignments were made in accordance with the randomization order determined by RAY.
In the collection of data; "personal information form", "numerical pain scale", "newcastle
nursing care satisfaction scale" and vital signs registration form were used.
Data were collected by the first researcher by face-to-face interview method between October
2020 and May 2021. Patients who met the inclusion criteria were recruited three days a week
and on weekends after surgery.
A single post-operative session (30 minutes) of foot reflexology was applied to patients with
abdominal surgery in the intervention group by the first investigator who had received
reflexology practice training before starting the study. Patient privacy was respected in all
procedures. During the application, it was ensured that the ambient sounds were as quiet and
calm as possible. The monitor and phones were set to silent mode, and the television was
turned off during the application. The bed-ends were removed, the patient was asked to lie in
the supine position, and the investigator supported the patient's feet with a pillow, ready
for reflexology. After these preparations, the researcher washed and dried his hands, took
some olive oil, rubbed his hands and brought it to body temperature. Personal information
form was applied before the reflexology application. As a pre-test, pain and nursing
satisfaction levels were evaluated with newcastle nursing care satisfaction scale. Then,
vital signs (systolic blood pressure, diastolic blood pressure, pulse, respiration and
saturation) were measured. Foot warming movements, which is the first stage of foot
reflexology, were applied to the left foot for 5 minutes. As foot warming movements; Achilles
tendon stretching, rotation, executing the thumbs of the hand under the foot, bilateral wrist
loosening and laundry tightening were performed using several methods. Then, the warm-up
movements were terminated by applying deep and painless pressure to the solar plexus area of
the left foot for 1 minute. Then in order; Reflexology was applied to the brain (pineal and
pituitary region in the thumb, hypothalamus), lymphatic system, tension region (projection of
the solar plexus on the foot), lung, adrenal gland, thyroid, diaphragm, stomach and joint
regions. Afterwards, relaxation movements were made for the foot, pressure was applied to the
solar plexus and the reflexology application was completed within 30 minutes. Immediately
after the application, vital signs were re-measured as a post-test, and numerical pain scale
and newcastle nursing care satisfaction scale were re-applied.
To the patients in the control group; personal information form, numerical pain scale and
newcastle nursing care satisfaction scale were used as pre-tests. After the questions were
answered, numerical pain scale and newcastle nursing care satisfaction scale were
re-administered 30 minutes later as a post-test without any intervention other than the
clinical protocol.
