The Effect of Foot Reflexology on Patient Satisfaction, Pain, and Vital Signs After Abdominal Surgery

Sponsor
Gurkan Kapikiran (Other)
Overall Status
Completed
CT.gov ID
NCT05103163
Collaborator
(none)
156
1
2
11.5
13.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Foot Reflexology
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Which of the patients included in the study would be in the experimental group and which would be in the control group was determined 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.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Foot Reflexology on Patient Satisfaction, Pain, and Vital Signs After Abdominal Surgery
Actual Study Start Date :
Oct 10, 2020
Actual Primary Completion Date :
May 10, 2021
Actual Study Completion Date :
Sep 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Foot reflexology group

Before the reflexology application, a personal information form was applied to the patients who had abdominal surgery. As a pre-test, satisfaction levels in terms of pain and nursing were evaluated. Then, vital signs (systolic blood pressure, diastolic blood pressure, pulse, respiration and saturation) were measured. Foot warming movements were started and then the warming movements were terminated by applying pressure to the solar plexus area of the left foot. Then in order; Reflexology was applied to the brain, lymphatic system, blood pressure area, lung, adrenal gland, thyroid, diaphragm, stomach and joint areas. 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 the numerical pain scale and care satisfaction scale were applied again.

Other: Foot Reflexology
Reflexology application is an energy balancing system with its own pressure technique that provides recovery by rubbing the reflex (nerve endings) points, stroking and applying pressure during squeezing movements. Thanks to the pressure and massage applie

No Intervention: No treatment group

To the patients in the control group; Personal Information Form, Numerical Pain Scale (NPS) and Newcastle Nursing Care Satisfaction Scale (NNCSS) were applied as pre-test. After the questions were answered, NNCSS with NPS was applied again 40 minutes later as a final test, without any intervention other than the clinical protocol.

Outcome Measures

Primary Outcome Measures

  1. Patient Satisfaction [0-30 minutes]

    It is a Likert-type scale, scored between 1 and 5, consisting of 19 questions containing patients' views of satisfaction with nursing care.

  2. Pain Level [0.-30. minutes]

    It is a numeric scale which is based on explaining pain severity with numbers, and where 0 point means no pain and 10 points mean unbearable pain

  3. Blood pressure measurement [0.-30. minutes]

    Systolic blood pressure was measured with a digital sphygmomanometer (mm Hg).

  4. Blood pressure measurement [0.-30. minutes]

    Diastolic blood pressure was measured with a digital sphygmomanometer (mm Hg).

  5. Pulse measurement [0.-30. minutes]

    The patient's heart rate in 1 minute was measured.

  6. Respiratory rate measurement [0.-30. minutes]

    The respiratory rate of the patient in 1 minute was measured.

  7. oxygen saturation measurement [0.-30. minutes]

    Oxygen saturation was measured with a pulse oximeter device.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Turgut Ozal Medical Center Malatya Turkey 44090

Sponsors and Collaborators

  • Gurkan Kapikiran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gurkan Kapikiran, Assistant Professor, Inonu University
ClinicalTrials.gov Identifier:
NCT05103163
Other Study ID Numbers:
  • 2020/2
First Posted:
Nov 2, 2021
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gurkan Kapikiran, Assistant Professor, Inonu University

Study Results

No Results Posted as of Nov 2, 2021