Clinical trial NCT05103163: The Effect of Foot Reflexology on Patient Satisfaction, Pain, and Vital Signs After Abdominal Surgery
Official title: The Effect of Foot Reflexology on Patient Satisfaction, Pain, and Vital Signs After Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Abdominal Surgery
Foot Reflexology
Vital Signs
Patient Satisfaction
Pain
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and above who are open to communication,
* Hospitalized for at least two nights
* Defining the severity of pain as 4 and above,
* Any lesion, wound, infection, etc. that prevents the practice of standing reflexology. non,
* Not diagnosed with cancer
* Deep vein thrombosis, epilepsy, Thrombophlebitis, febrile diseases etc. without diseases,

Exclusion Criteria:

* Presence of any lesion, wound, infection etc. on the foot
* Presence of deep vein thrombosis
* Presence of epilepsy
* With thrombophlebitis and febrile diseases
* Those who do not volunteer to participate in the study,

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 0-30 minutes
measure: Pain Level
timeFrame: 0.-30. minutes
measure: Blood pressure measurement
timeFrame: 0.-30. minutes
measure: Blood pressure measurement
timeFrame: 0.-30. minutes
measure: Pulse measurement
timeFrame: 0.-30. minutes
measure: Respiratory rate measurement
timeFrame: 0.-30. minutes
measure: oxygen saturation measurement
timeFrame: 0.-30. minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Turgut Ozal Medical Center
Study officials:
References: