NCT06407622

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

February 2, 2024

Last Update Submit

May 6, 2024

Conditions

Keywords

NursingPainReflexologyAbdominal PainSleep QualityBowel FunctionsAppendectomy

Outcome Measures

Primary Outcomes (3)

  • 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.

    initial postoperative evaluation, 1st hour and 3rd hour

  • 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.

    24 hours after surgery

  • 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.

    initial postoperative evaluation, 1st hour and 3rd hour

Study Arms (2)

Patients undergoing appendectomy surgery who received foot reflexology

EXPERIMENTAL

The 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.

Other: Foot Reflexology

Patients who underwent appendectomy surgery without foot reflexology

NO INTERVENTION

The 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.

Interventions

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.

Also known as: Foot, Reflexology
Patients undergoing appendectomy surgery who received foot reflexology

Eligibility Criteria

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

You may qualify if:

  • 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,
  • 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.

You may not qualify if:

  • Complications developed after appendectomy surgery,
  • Pain score \&lt;4 according to the Visual Analog Scale,
  • Those with hypertension problems,
  • Unable to communicate,
  • Having visual or auditory problems,
  • Having a diagnosed psychiatric problem,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Bartın, Centrical, 74100, Turkey (Türkiye)

Location

Related Publications (14)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

PainAbdominal PainSleep Initiation and Maintenance Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Sevim ÇELİK, Prof

    Bartın University Health Science Faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: The thesis study was planned as a randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

February 2, 2024

First Posted

May 9, 2024

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 10, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations