SurgeryNCT05103163
The Effect of Foot Reflexology on Patient Satisfaction, Pain, and Vital Signs After Abdominal Surgery
A study testing Foot Reflexology in people with Surgery, run by Gurkan Kapikiran at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Foot Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2020to 25 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Foot Reflexology
- Keywords
- Abdominal Surgery, Foot Reflexology, Vital Signs, Patient Satisfaction, Pain
- Medical subject headings
- Patient Satisfaction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot ReflexologyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 0.-30. minutes
Blood pressure measurement
Systolic blood pressure was measured with a digital sphygmomanometer (mm Hg).
Measured: 0.-30. minutes
Blood pressure measurement
Diastolic blood pressure was measured with a digital sphygmomanometer (mm Hg).
Measured: 0.-30. minutes
Pulse measurement
The patient's heart rate in 1 minute was measured.
Measured: 0.-30. minutes
Respiratory rate measurement
The respiratory rate of the patient in 1 minute was measured.
Measured: 0.-30. minutes
oxygen saturation measurement
Oxygen saturation was measured with a pulse oximeter device.
Measured: 0.-30. minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start10 Oct 2020
- Primary completion10 May 2021
- Study completion25 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gurkan Kapikiran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gurkan Kapikiran, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103163
- Sponsor's protocol ID
- 2020/2
- Status last verified
- Oct 2021
- First submitted
- 3 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Reflexology on Patient Satisfaction, Pain, and Vital Signs After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05103163
- Acronym / sponsor ID
- 2020/2
- Conditions
- Surgery
- Keywords
- Abdominal Surgery, Foot Reflexology, Vital Signs, Patient Satisfaction, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Gurkan KapikiranUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 25 Sep 2021 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foot reflexology group | Experimental | Other: Foot ReflexologyBefore 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot ReflexologyReflexology 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 | Other | Foot reflexology group |
Primary outcome
Patient Satisfaction
Time frame: 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.
Pain Level
Time frame: 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
Blood pressure measurement
Time frame: 0.-30. minutes
Systolic blood pressure was measured with a digital sphygmomanometer (mm Hg).
Blood pressure measurement
Time frame: 0.-30. minutes
Diastolic blood pressure was measured with a digital sphygmomanometer (mm Hg).
Pulse measurement
Time frame: 0.-30. minutes
The patient's heart rate in 1 minute was measured.
Respiratory rate measurement
Time frame: 0.-30. minutes
The respiratory rate of the patient in 1 minute was measured.
oxygen saturation measurement
Time frame: 0.-30. minutes
Oxygen saturation was measured with a pulse oximeter device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Reflexology in people with Surgery, run by Gurkan Kapikiran at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 0-30 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.