NCT05486533

Brief Summary

This randomized controlled study evaluates the effect of acupressure application on the pain level patients after angioography. The hypothesis of this study is that acupressure reduces pain levels and stabilizes hemodynamic variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

August 1, 2022

Last Update Submit

January 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain evaluated using the visual analog scale

    The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.

    Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

Secondary Outcomes (5)

  • Systolic blood pressure

    Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

  • Diastolic blood pressure

    Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

  • Heart rate

    Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

  • Respiratory rate

    Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

  • Peripheral oxygen saturation

    Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

Study Arms (2)

Experimental

EXPERIMENTAL

The experimental group will be given acupressure.

Other: Acupressure

Control

NO INTERVENTION

It will only take routine treatment and care.

Interventions

The experimental group will start with LI4 points and continue P6 and LI11 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.

Also known as: Acupress
Experimental

Eligibility Criteria

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

You may qualify if:

  • Agreeing to participate in the research (signing the Informed Consent Form),
  • Conscious and cooperative,
  • Speaks and understands Turkish,
  • Over 18 years of age,
  • Stable general condition,
  • No sensitivity in the area where acupressure will be applied,
  • No active COVID-19 infection,
  • Patients without any psychiatric diagnosis will be included.

You may not qualify if:

  • Do not agreeing to participate in the research (signing the Informed Consent Form),
  • Do not conscious and cooperative,
  • Do not speaks and understands Turkish,
  • Do not over 18 years of age,
  • Do not stable general condition,
  • Having sensitivity in the area where acupressure will be applied,
  • Having active COVID-19 infection,
  • Patients with any psychiatric diagnosis will be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey, Mersin University,

Mersin, Turkey/Mersin,Yenişehir, 33343, Turkey (Türkiye)

Location

Related Publications (2)

  • Rajaee, N., Choopani, N., Pishgoei, A. H., & Sharififar, S. (2015). The effect of acupressure on Patient's anxiety who candidate for coronary angiography. Military Caring Sciences, 1 (3), 6-13.

    BACKGROUND
  • The effect of acupressure on vital signs, acute pain, stress and satisfaction during venipuncture: Single-blind, randomized controlled study. European

    RESULT

MeSH Terms

Conditions

PainPeripheral Vascular Diseases

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gülay Altun Uğraş, PhD

    Mersin University

    STUDY DIRECTOR
  • Canan KANAT, Master

    Mersin University

    PRINCIPAL INVESTIGATOR
  • Barış DÜZEL, Specialist

    Mersin City Research and Application Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the research, participants and researchers cannot be blinded. Analyzes will be made by a biostatistician independent of the research and the statistician will be blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, parallel, three-arm randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 3, 2022

Study Start

November 25, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations