NCT06312397

Brief Summary

This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 4, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 6, 2024

Last Update Submit

March 12, 2024

Conditions

Keywords

Coronary angiographyAcupressureLow back painFatigue, Muscle

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale for Pain

    It is used to measure subjectively perceived pain. On the scale, which includes the numbers between 0 and 10 cm, which are the most commonly used to determine the intensity of pain quantitatively, with painlessness at one end and the most severe pain possible at the other end, "0" defines painlessness and "10" defines the most severe pain.

    1 year

  • Visual Analog Scale for Fatigue

    The fatigue scale is a 10 cm scale that evaluates the severity of fatigue ranked from 0 to 10. On the left side of the scale, there is a rating of "I do not feel tired", and on the right side, there is a rating of "I feel extreme fatigue and exhaustion".

    1 year

Study Arms (3)

Acupressure group

ACTIVE COMPARATOR

After coronary angiography, acupressure will be applied for a total of 15 minutes. For the acupressure group, a total of three points will be applied: the heart meridian 7th point (HT7), the large intestine meridian 4th point (LI4), and the stomach meridian 36th point (ST36), which is deemed appropriate in the lower extremity. The symmetry of the three selected different points will also be applied to the other extremity.

Other: Acupressure

Sham acupressure

PLACEBO COMPARATOR

In the acupressure application applied to the sham group, parallel pressure will be applied to the bone area and points where the HT7, LI4, ST36 meridians do not pass.

Other: Sham acupressure

Control group

NO INTERVENTION

With the control group, no intervention was conducted, and only standard care was given.

Interventions

For the acupressure group, a total of three points will be applied: the heart meridian 7th point (HT7), the large intestine meridian 4th point (LI4), and the stomach meridian 36th point (ST36), which is deemed appropriate in the lower extremity The symmetry of the three selected different points will also be applied to the other extremity. After coronary angiography, acupressure will be applied for a total of 15 minutes.

Acupressure group

In the acupressure application applied to the sham group, parallel pressure will be applied to the bone area and points where the HT7, LI4, ST36 meridians do not pass.

Sham acupressure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned coronary angiography from the femoral region
  • Not diagnosed with low back pain
  • No stent or other interventional procedure was performed during the coronary angiography procedure.

You may not qualify if:

  • Those who have had acupressure before for any purpose
  • Problems such as bleeding and dysrhythmia occur after coronary angiography,
  • Those with burns, scars, scratches and deformities at the acupressure point
  • Having any psychological disorder,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birgül VURAL DOĞRU

Mersin, 33110, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back PainFatigue

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients in the acupressure and sham acupressure groups were blinded as to which groups they were in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Three groups ( acupressure group, sham acupressure group and control group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 15, 2024

Study Start

March 4, 2024

Primary Completion

July 30, 2024

Study Completion

August 30, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

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