NCT06853860

Brief Summary

There is no study finding examining the effects of the classical hand massage and hand reflexology massage methods on pain, anxiety and physiological parameters after coronary angiography. Therefore, the aim of this study is to examine the effects of reflexology hand massage and classical hand massage on pain, anxiety and physiological parameters after coronary angiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

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

February 15, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

December 24, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

February 25, 2025

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Average Pain Score on Visual Analog Scale (VAS)

    Pain will be measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (severe pain). Higher scores indicate more severe pain.

    0 hour (baseline), 1st hour, 2nd hour, 3rd hour

  • State Anxiety Scale Mean Score

    Anxiety will be measured using the State Anxiety Scale, a validated questionnaire assessing current anxiety levels. Higher scores indicate higher levels of anxiety.

    0 hour (baseline), 1st hour, 2nd hour, 3rd hour

Study Arms (2)

reflexology group

EXPERIMENTAL

reflexology group

Other: reflexology massage

Classic hand massage group

PLACEBO COMPARATOR

Classic hand massage group

Other: classic hand massage

Interventions

classic hand massage

Classic hand massage group

classic hand massage

reflexology group

Eligibility Criteria

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

You may qualify if:

  • Patients who are over 18 years old
  • Can speak Turkish
  • Agree to participate in the study
  • Have not undergone emergency coronary angiography
  • Have not consumed coffee or hypnotic drugs at least 12 hours before
  • Have no history of chronic pain (e.g. arthritis)
  • Are not addicted to alcohol or drugs
  • Have no psychological problems (such as depression, anxiety disorder)
  • Have no problem with having their hands massaged; those who do not have any skin lesions, sensory and motor disorders, amputations, burns, or pathological diseases related to muscles and bones
  • Have not used anxiolytics

You may not qualify if:

  • Those who do not volunteer to participate in the study
  • Those who have any skin lesions, burns, open wounds, muscle and bone pathological diseases on their hands,
  • Those who develop delirium during the follow-up period
  • Those who develop complications after coronary angiography (such as bleeding, etc.)
  • Arrhythmia
  • Hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necibe

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Vascular DiseasesAcute Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Burcu NAL, PhD

    Kütahya Health Sciences University, Faculty of Health Sciences

    STUDY DIRECTOR
  • Mehmet Ali ASTARCIOĞLU, Prof.

    Kütahya Health Sciences University, Faculty of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Patients will be divided into experimental and control groups. Patients will know that they are participating in the study and the interventions that will be applied to them, but they will be blinded by not knowing which group they are in. The study data will be collected by a second researcher who is blinded to the groups. In the statistical analysis of the data, the groups will be labeled as group 1 and group 2, and the third researcher will be blinded when evaluating the results. Thus, the third researcher will be blinded to the study groups. In order to avoid bias in the evaluation of the results, the first researcher who is not blinded will not participate in any stage of the evaluation process.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a double-blind randomized controlled trial planned to investigate the effects of hand massage applied with two different methods on pain, anxiety and physiological parameters in patients undergoing coronary angiography.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Nursing

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 3, 2025

Study Start

February 15, 2025

Primary Completion

May 15, 2025

Study Completion

July 15, 2025

Last Updated

December 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations