NCT04756999

Brief Summary

Reflexology is massage therapy used to maintain and improve health, as well as relieve some symptoms. Foot reflexology, which is thought to have an effect on dialysis symptoms, will be applied to hemodialysis patients in 9 sessions. In this study, it is aimed to determine the effect of foot reflexology applied to dialysis patients on sleep, anxiety and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

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 12, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2021

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

1.4 years

First QC Date

February 12, 2021

Last Update Submit

June 20, 2022

Conditions

Keywords

reflexologydialysisnursing care

Outcome Measures

Primary Outcomes (1)

  • sleep

    improvement in sleep quality. The patients' sleep quality score were collected by the Richard-Campbell Sleep Questionnaire. The scale has a 100-mm line with words describing the poorest possible sleep (0 mm) to the best possible sleep (100 mm).

    nine sessions of foot reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands for 3 weeks.

Secondary Outcomes (1)

  • anxiety

    nine sessions of foot reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands for 3 weeks.

Study Arms (2)

Intervention

EXPERIMENTAL

informed consent forms, nine sessions of foot reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands for 3 weeks. Then data collection tools were applied.

Behavioral: massage therapy

Control

PLACEBO COMPARATOR

informed consent forms, foot massage were performed. Then data collection tools were applied.

Behavioral: massage therapy

Interventions

massage therapyBEHAVIORAL

Reflexology is massage therapy used to maintain and improve health, as well as relieve some symptoms.

ControlIntervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Conscious and oriented with no communication problem
  • Agreeing to participate in the study
  • Receiving hemodialysis treatment 3 times a week for 6 months or more
  • Patients who have no problem to apply massage; Those who do not have any skin lesions, burns, pathological diseases related to muscles and bones, phlebitis, embolism or bleeding disorder.

You may not qualify if:

  • Patients who have received hemodialysis treatment for less than 6 months.
  • Patients with diabetic neuropathy
  • Those who have any skin lesions, burns, open wounds, muscle and bone-related pathological disease, phlebitis, embolism or bleeding disorder in the foot.
  • Patients with infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başkent University, İzmir Çiğli Dialysis Center

Izmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gülşah Gürol Arslan, PhD

    Associate professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Blind Randomised Controlled Trial
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 16, 2021

Study Start

January 12, 2020

Primary Completion

June 20, 2021

Study Completion

June 20, 2021

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations