NCT05103163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

October 3, 2021

Last Update Submit

October 28, 2021

Conditions

Keywords

Abdominal SurgeryFoot ReflexologyVital SignsPatient SatisfactionPain

Outcome Measures

Primary Outcomes (7)

  • Patient Satisfaction

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

    0-30 minutes

  • Pain Level

    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

    0.-30. minutes

  • Blood pressure measurement

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

    0.-30. minutes

  • Blood pressure measurement

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

    0.-30. minutes

  • Pulse measurement

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

    0.-30. minutes

  • Respiratory rate measurement

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

    0.-30. minutes

  • oxygen saturation measurement

    Oxygen saturation was measured with a pulse oximeter device.

    0.-30. minutes

Study Arms (2)

Foot reflexology group

EXPERIMENTAL

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

No treatment group

NO INTERVENTION

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.

Interventions

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

Foot reflexology group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turgut Ozal Medical Center

Malatya, 44090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient SatisfactionPain

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 3, 2021

First Posted

November 2, 2021

Study Start

October 10, 2020

Primary Completion

May 10, 2021

Study Completion

September 25, 2021

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations