NCT04934241

Brief Summary

This study will be conducted to evaluate the effect of acupressure applied to patients with coronary artery disease (CAD) on pain and sleep quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable coronary-artery-disease

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

June 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

June 28, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

June 15, 2021

Last Update Submit

August 23, 2021

Conditions

Keywords

Self-AcupressureSleepPainCoronary Artery Patıent

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale (VAS)

    The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. VAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm

    1. week

  • Visual Analog Scale (VAS)

    The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. VAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm

    4. week

  • Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is \>5 indicates "poor sleep"

    1. week

  • Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is \>5 indicates "poor sleep"

    4. week

Study Arms (2)

Self-Acupressure

EXPERIMENTAL

Self-Acupressure Each application to the acupressure points (HT 7, CV17,PC 6, LI4,SP 6) will be done in 2 minutes and right and left)

Other: Self-Acupressure

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body

Self-Acupressure

Eligibility Criteria

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

You may qualify if:

  • Not having a psychiatric diagnosis,
  • To be able to communicate adequately
  • Not having psychiatric problems
  • Volunteering to participate in research

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

Location

Related Publications (1)

  • Narimani M, Ansari Jaberi A, Negahban Bonabi T, Sadeghi T. Effect of Acupressure on Pain Severity in Patients Undergoing Coronary Artery Graft: A Randomized Controlled Trial. Anesth Pain Med. 2018 Oct 20;8(5):e82920. doi: 10.5812/aapm.82920. eCollection 2018 Oct.

MeSH Terms

Conditions

Coronary Artery DiseasePain

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zülfünaz ÖZER, PhD

    Istanbul Sabahattin Zaim University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Self-Acupressure and control group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is an experimental study with pre-test and post-test control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD., Assistant Prof

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 22, 2021

Study Start

June 28, 2021

Primary Completion

July 28, 2021

Study Completion

August 9, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations