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Active, not recruitingNCT06007716Updated Aug 23, 2023

The Effect Of Reflexology On Pain, Anxiety And Comfort Level

An interventional study of reflexology massage and Placebo massage in Myocardial Infarction and Angina Pectoris, sponsored by Hakkari Universitesi. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-23.

Sponsored by Hakkari Universitesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jul 2021, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study was performed as a randomized controlled a study with a pre test-post test design, aimed to determine affect of reflexology masagge to the pain, anxiety and comfort level on the patients that are percutaneous coronary intervention.

Read the detailed description

A total of 74 patients, 37 in the experimental group and 37 in the placebo group, who met the criteria for inclusion in the study, constituted the sample of the study. Research data were collected with "Structured Patient Information Form", "Vital Signs Form", "State Anxiety Scale", "Visual Comparison Scale", "McGill Pain Scale Short Form" and "General Comfort Scale Short Form". Appropriate statistical methods were used in the analysis of the data.

Reflexology massage is a well tolerated, inexpensive, applicable and safe non-pharmacological method. The fact that nurses are educated and experienced about reflexology massage is of great importance for integrating reflexology massage into clinical settings.

If the results of this study are significant, it will be concluded that reflexology massage is effective in the management of pain and anxiety and increasing the comfort level in patients undergoing PCI. It will be recommended that reflexology massage be used in clinics to reduce pain, anxiety and increase comfort level in individuals undergoing PCI, and to include it in patient education. No study has been found in the national literature evaluating the effectiveness of reflexology massage in the management of PCI-related pain, anxiety and comfort. It is thought that this study will fill an important gap in the literature. The aim of this study, carried out in this context, is to reveal the effect of reflexology massage on pain, anxiety and comfort level in patients undergoing PCI.

02

Conditions studied

  • Myocardial Infarction
  • Angina Pectoris
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 74 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Hakkari Universitesi is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Over 18 years old,
  • Literate, Diagnosed with PCI-related pain,
  • Pain score of 4 out of 10 according to Visual Comparison Scale (VAS) after PCI.

Exclusion criteria

Exclusion Criteria:

  • Presence of a pacemaker,
  • Having a diagnosis of diabetic foot,
  • Presence of vision, hearing, cognitive ability impairment or psychosis,
  • Being pregnant,
  • Presence of disc herniation,
  • Any contagious skin disease (shingles, fungus, etc.), open lesion/wound on the lower extremities, scar tissue, fracture, dislocation, amputation, edema, hematoma, thrombophlebitis, inflammatory and degenerative joint disease,
  • Having applied reflexology massage in the last month
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
74 participants (actual)

Study arms

  • Active comparator
    Experimental group

    it was planned to apply reflexology massage once a day for each patient for 2 consecutive days, in total 2 sessions.

    Other: reflexology massage

  • Placebo comparator
    placebo group

    placebo massage was applied once a day for each patient for 2 consecutive days, for a total of 2 sessions.

    Other: Placebo massage

Interventions

  • Otherreflexology massage

    5 minutes of classic message on the left foot, 15 minutes of reflexology message, and 5 minutes of classic message on the right foot, 15 minutes of reflexology message, a total of 40 minutes of massage. 30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, reflexology massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions.

  • OtherPlacebo massage

    Placebo reflexology massage was applied to each foot for 20 minutes, for a total of 40 minutes.30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, Placebo massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions.

06

What researchers measure

Primary outcomes

  1. The McGill Pain Scale Short Form-2

    The McGill Pain Scale Short Form, developed by Melzack in 1987, provides information about the sensory characteristics, severity and effect of pain. The validity and reliability study in Turkey was developed by Yakut et al. in 2007. McGill Pain Scale Short Form-2 (MAS-SF-2) was developed in 2010 by revising the McGill Pain Scale Short Form by Bicici and Günes.

    Time frame: 2 days

Secondary outcomes

  1. State-Trait Anxiety Inventory

    It was developed by Spielberger et al. in 1970 and validated and reliable in Turkish society by Öner and Le Compte (1977). The State-Trait Anxiety Inventory consists of two different parts and includes a total of 40 items, 20 of which are each.

    Time frame: 2 days

Other outcomes

  1. General Comfort Scale Short Form

    General Comfort Scale Short Form GQS-SF was developed by Kolcaba in 2006. Validity and reliability were established by Saritas et al. in 2018. It includes the sub-dimensions of comfort, relief (9 items), relaxation (9 items), and overcoming problems (10 items).

    Time frame: 2 days

07

Study locations

1 site
  • Van Regional Training and Research Hospital
    Van, 65100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06007716
Lead sponsor
Hakkari Universitesi
Responsible party
Kamber Sumer (Assistant professor, Hakkari Universitesi) — Principal investigator
First posted
Aug 23, 2023
Start date
Jul 1, 2021
Primary completion
Feb 27, 2022
Completion
Sep 30, 2023 (estimated)
Last update
Aug 23, 2023

Study contacts

Kamber SÜMER
principal investigator · PhD student

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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