Clinical trial NCT05486533: The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables
Official title: The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupressure
Pain
Hemodynamic Instability
Angiopathy, Peripheral
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, three-arm randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: In the study, 124 patients will randomly assigned to acupressure/experimental group and control group. To the acupressure/experimental group (n = 62), an average of 15 minutes will be applied to the LI4 (liver, between thumb and forefinger), P6 (pericardium, three fingers above the wrist) and LI 11 is located the area where the elbow bend. On the other hand, no other intervention will be applied to the control group other than routine treatment and nursing care. The primary outcome of the research is the effect of acupressure on the pain of patients. The secondary outcome of the study is to determine the effect of acupressure on the hemodynamic variables. The pain and hemodynamic variables will be collected before, immediately after the application, 10th, 20th and 30th minutes after the application. Data will also be collected from the control group at the same time.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain evaluated using the visual analog scale
timeFrame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
measure: Diastolic blood pressure
timeFrame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
measure: Heart rate
timeFrame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
measure: Respiratory rate
timeFrame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
measure: Peripheral oxygen saturation
timeFrame: Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Turkey, Mersin University,
state: Turkey/Mersin,Yenişehir
Study officials:
affiliation: Mersin University
name: Gülay Altun Uğraş, PhD
role: STUDY_DIRECTOR
affiliation: Mersin University
name: Canan KANAT, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin City Research and Application Hospital
name: Barış DÜZEL, Specialist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: The effect of acupressure on vital signs, acute pain, stress and satisfaction during venipuncture: Single-blind, randomized controlled study. European