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NursingNCT06407622

The Effect of Foot Reflexology on Patients Undergoing Appendectomy Surgery

A study testing Foot Reflexology in people with Nursing and Pain, run by Bartın Unıversity at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pain is an unpleasant experience that can negatively affect all aspects of the patients life and lead to a decrease in quality of life. Pain can also be encountered as a reason for a surgical intervention. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nursing, Pain, Reflexology
What is being tested?
Foot Reflexology
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2023to 10 Jan 2024
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 and over,
  • Having undergone appendectomy surgery,
  • No complications such as bleeding, nausea or vomiting after appendectomy surgery,
  • Not using patient-controlled analgesia for postoperative pain control,
  • Pain score ≥4 according to the Visual Analog Scale,
  • No hypertension problems,
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  • Able to speak and understand Turkish
  • No visual or auditory problems,
  • No diagnosed psychiatric problems,
  • No diagnosed bowel problems,
  • Do not have infectious skin diseases on their feet (such as zoster, fungus, warts, eczema),
  • Patients who do not have deep vein thrombosis, tombophlebitis, any fracture, neuropathy, osteomyelitis, osteoporosis, or ligament injury in their feet or legs,
  • Volunteer patients will be included.

Who cannot join

  • • Complications developed after appendectomy surgery,
  • Pain score \<4 according to the Visual Analog Scale,
  • Those with hypertension problems,
  • Unable to communicate,
  • Having visual or auditory problems,
  • Having a diagnosed psychiatric problem,
Show all 10Show fewer
  • Having a diagnosed bowel problem,
  • Those with infectious skin diseases on their feet (such as zoster, fungus, warts, eczema),
  • Patients with deep vein thrombosis, tombophlebitis, any fracture, neuropathy, osteomyelitis, osteoporosis, ligament injury in the foot and leg,
  • Non-voluntary patients will be excluded from the scope.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Bartın University

    Bartın, Centrical, 74100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Foot Reflexology on Pain Intensity, Sleep Quality and Bowel Functions in Patients Undergoing Appendectomy Surgery

Pain is an unpleasant experience that can negatively affect all aspects of the patients life and lead to a decrease in quality of life. Pain can also be encountered as a reason for a surgical intervention. For this reason, it has become one of the most common problems experienced by patients in the postoperative period. Pain management is a universal requirement in health care and is of great importance for patients. If the pain is not managed well in the postoperative period, it may cause some complications in the patient. If pain is controlled, early discharge of the patient, lower healthcare costs and increased patient satisfaction are achieved. In terms of providing effective pain control, it is provided by nurses, who are health professionals, to spend more time with the patient, to lead the patient in pain management and to analyze the results. The aim of the thesis study is to evaluate the effect of foot reflexology on pain intensity, sleep quality and bowel functions in patients who have undergone appendectomy surgery.

Read the detailed description

Optimal management of postoperative pain is associated with reduced morbidity and faster recovery times, as well as improved physical function and quality of life. Despite efforts to minimize postoperative pain, 61% of outpatients still experience moderate/extreme pain upon discharge. Pain management is an important aspect of patient care, and nurses play an important role in providing pain assessment and treatment in the acute care setting. The use of non-pharmacological pain relief techniques has been found to be effective with fewer side effects and complications. Reflexology, one of the types of complementary and alternative medicine, has begun to be used as a nursing intervention along with modern medicine as a non-pharmacological method. When the investigators look at the past years; The effects of foot reflexology on pain intensity, nausea, anxiety, delirium, and hemodynamic parameters were investigated. The studies conducted include cancer patients, burn patients, intensive care patients and dialysis patients. However, in previous studies, no study was found investigating the effect of foot reflexology on sleep quality and bowel functions in patients undergoing surgical intervention. This study is thought to be the first to evaluate the effect of foot reflexology on sleep quality and bowel functions in surgical patients. In this respect, it is a study that will contribute to the literature.

Being tested
Foot Reflexology
Keywords
Nursing, Pain, Reflexology, Abdominal Pain, Sleep Quality, Bowel Functions, Appendectomy
Medical subject headings
Pain, Abdominal Pain, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foot ReflexologyOther

    Also called Foot, Reflexology

    In previous studies, no study was found investigating the effect of foot reflexology on sleep quality and bowel functions in patients undergoing surgical intervention. This study is thought to be the first to evaluate the effect of foot reflexology on sleep quality and bowel functions in surgical patients. In this respect, it is a study that will contribute to the literature.

Study groups in NCT06407622
Study groupRoleWhat they receive
Patients undergoing appendectomy surgery who received foot reflexologyExperimentalThe study will be carried out with 120 patients hospitalized after appendectomy surgery in the surgical clinic of Bartın State Hospital. In the postoperative period, patients will be divided into experimental (n = 60) and control (n = 60) groups by block randomization with a computer-aided program.
Receives: Other: Foot Reflexology
Patients who underwent appendectomy surgery without foot reflexologyNo interventionThe study will be carried out with 120 patients hospitalized after appendectomy surgery in the surgical clinic of Bartın State Hospital. In the postoperative period, patients will be divided into experimental (n = 60) and control (n = 60) groups by block randomization with a computer-aided program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Effect of Foot Reflexology on Pain Intensity

    In this study, foot reflexology will be applied to patients who have undergone appendectomy surgery. After this reflexology, patients' pain intensity will be evaluated. When the patients come out of appendectomy surgery, their pain will be evaluated with visual analog scale(VAS). Then, no intervention will be applied to the control group. Foot reflexology massage will be applied to the patients in the intervention group at the 1st hour postoperatively and pain values will be measured with VAS at 5 minutes, 30 minutes and 60 minutes after this application. At the 3rd hour postoperatively, reflexology massage will be performed for the 2nd time and pain intensity will be evaluated with VAS at 5 minutes, 30 minutes and 60 minutes after the re-massage.

    VAS pain score is evaluated as "no pain" (score=0) and "worst pain" (score=10). score <3 is reported as mild pain, 3-6 as mild-moderate pain and >6 as moderate-severe pain.

    Measured: initial postoperative evaluation, 1st hour and 3rd hour

  2. The Effect of Foot Reflexology on Sleep Quality

    After appendectomy surgery, no intervention will be applied to the control group, while foot reflexology will be applied to the intervention group at the 1st and 3rd hour after surgery. At 24 hours, the sleep quality of the intervention and control group patients will be evaluated with the Richard Cambple Sleep Scale.

    Richard Campbell sleep scale consists of 6 items. Total scoring is based on the first 5 items. Each item is evaluated on a scale of 0-100 with the visual analog scale technique. A score of 0-25 on the scale indicates very poor sleep and 76-100 indicates very good sleep.

    Measured: 24 hours after surgery

  3. The Effect of Foot Reflexology on Bowel Function

    After appendectomy, bowel functions of the control and intervention groups will be evaluated. Afterwards, foot reflexology will be applied to the intervention group at the 1st and 3rd hour and their bowel functions will be evaluated on the bowel monitoring form. The control group will be evaluated at the 1st hour and 3rd hour after surgery without any intervention. Bowel functions will be recorded on the bowel function monitoring form created by the researcher. This form includes parameters such as the time of the first flatulence, the time of the first defecation, the time of oral feeding, and the time of the first mobilization.

    Measured: initial postoperative evaluation, 1st hour and 3rd hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2024
  2. Study start1 Jan 2023
  3. Primary completion1 Jan 2024
  4. Study completion10 Jan 2024

Resources

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
The thesis study was planned as a randomized controlled experimental study.
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06407622
Sponsor's protocol ID
BartınU-SBF-BKÇ-01
Status last verified
May 2024
First submitted
2 Feb 2024
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zeidabadinejad S, Mangolian Shahrbabaki P, Dehghan M. Effect of Foot Reflexology on Sexual Function of Patients under Hemodialysis: A Randomized Parallel Controlled Clinical Trial. Evid Based Complement Alternat Med. 2021 Oct 21;2021:8553549. doi: 10.1155/2021/8553549. eCollection 2021.

    PubMed 34721645

  • Wang WL, Hung HY, Chen YR, Chen KH, Yang SN, Chu CM, Chan YY. Effect of Foot Reflexology Intervention on Depression, Anxiety, and Sleep Quality in Adults: A Meta-Analysis and Metaregression of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2020 Sep 15;2020:2654353. doi: 10.1155/2020/2654353. eCollection 2020.

    PubMed 33014101

  • Taheri H, Naseri-Salahshour V, Abedi A, Sajadi M. Comparing the Effect of Foot and Hand Reflexology on Pain Severity after Appendectomy: A Randomized Clinical Trial. Iran J Nurs Midwifery Res. 2019 Nov 7;24(6):451-456. doi: 10.4103/ijnmr.IJNMR_85_18. eCollection 2019 Nov-Dec.

    PubMed 31772920

  • Samuel SR, Gururaj R, Kumar KV, Vira P, Saxena PUP, Keogh JWL. Randomized control trial evidence for the benefits of massage and relaxation therapy on sleep in cancer survivors-a systematic review. J Cancer Surviv. 2021 Oct;15(5):799-810. doi: 10.1007/s11764-020-00972-x. Epub 2020 Dec 2.

    PubMed 33269414

  • Samarehfekri A, Dehghan M, Arab M, Ebadzadeh MR. Effect of Foot Reflexology on Pain, Fatigue, and Quality of Sleep after Kidney Transplantation Surgery: A Parallel Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Aug 1;2020:5095071. doi: 10.1155/2020/5095071. eCollection 2020.

    PubMed 32831868

  • Rejeh N, Tadrisi SD, Yazdani S, Saatchi K, Vaismoradi M. The Effect of Hand Reflexology Massage on Pain and Fatigue in Patients after Coronary Angiography: A Randomized Controlled Clinical Trial. Nurs Res Pract. 2020 Aug 29;2020:8386167. doi: 10.1155/2020/8386167. eCollection 2020.

    PubMed 32908698

  • Paul RW, Szukics PF, Brutico J, Tjoumakaris FP, Freedman KB. Postoperative Multimodal Pain Management and Opioid Consumption in Arthroscopy Clinical Trials: A Systematic Review. Arthrosc Sports Med Rehabil. 2021 Dec 17;4(2):e721-e746. doi: 10.1016/j.asmr.2021.09.011. eCollection 2022 Apr.

    PubMed 35494281

  • Mwanza E, Gwisai RD, Munemo C. Knowledge on Nonpharmacological Methods of Pain Management among Nurses at Bindura Hospital, Zimbabwe. Pain Res Treat. 2019 Jan 1;2019:2703579. doi: 10.1155/2019/2703579. eCollection 2019.

    PubMed 30693106

  • Koffel E, Kats AM, Kroenke K, Bair MJ, Gravely A, DeRonne B, Donaldson MT, Goldsmith ES, Noorbaloochi S, Krebs EE. Sleep Disturbance Predicts Less Improvement in Pain Outcomes: Secondary Analysis of the SPACE Randomized Clinical Trial. Pain Med. 2020 Jun 1;21(6):1162-1167. doi: 10.1093/pm/pnz221.

    PubMed 31529104

  • Gordon-Williams R, Trigo A, Bassett P, Williams A, Cone S, Lees M, Brandner B. An Interactive Pain Application (MServ) Improves Postoperative Pain Management. Pain Res Manag. 2021 Apr 2;2021:8898170. doi: 10.1155/2021/8898170. eCollection 2021.

    PubMed 33868524

  • Ghanbari A, Shahrbabaki PM, Dehghan M, Mardanparvar H, Abadi EKD, Emami A, Sarikhani-Khorrami E. Comparison of the Effect of Reflexology and Swedish Massage on Restless Legs Syndrome and Sleep Quality in Patients Undergoing Hemodialysis: a Randomized Clinical Trial. Int J Ther Massage Bodywork. 2022 Jun 1;15(2):1-13. doi: 10.3822/ijtmb.v15i2.705. eCollection 2022 Jun.

    PubMed 35686176

  • Fazlollah A, Babatabar Darzi H, Heidaranlu E, Moradian ST. The effect of foot reflexology massage on delirium and sleep quality following cardiac surgery: A randomized clinical trial. Complement Ther Med. 2021 Aug;60:102738. doi: 10.1016/j.ctim.2021.102738. Epub 2021 May 21.

    PubMed 34029674

  • Blackburn L, Hill C, Lindsey AL, Sinnott LT, Thompson K, Quick A. Effect of Foot Reflexology and Aromatherapy on Anxiety and Pain During Brachytherapy for Cervical Cancer. Oncol Nurs Forum. 2021 May 1;48(3):265-276. doi: 10.1188/21.ONF.265-276.

    PubMed 33855996

  • Alinia-Najjar R, Bagheri-Nesami M, Shorofi SA, Mousavinasab SN, Saatchi K. The effect of foot reflexology massage on burn-specific pain anxiety and sleep quality and quantity of patients hospitalized in the burn intensive care unit (ICU). Burns. 2020 Dec;46(8):1942-1951. doi: 10.1016/j.burns.2020.04.035. Epub 2020 May 19.

    PubMed 32873443

Questions about this trial

What is this clinical trial studying?

A study testing Foot Reflexology in people with Nursing and Pain, run by Bartın Unıversity 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 13 inclusion and 10 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 9 May 2024. 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?

The Effect of Foot Reflexology on Pain Intensity (time frame: initial postoperative evaluation, 1st hour and 3rd hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06407622, which also lists 14 linked publications.

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 9 May 2024.

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