The Effect on Back Pain and Fatigue Level of Acupressure

Coronary Angiography Clinical Trial

Official title:

The Effect on Back Pain and Fatigue Level of Acupressure After Coronary Angiography: A Randomized, Single-Blind Sham-Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312397
• Other study ID #: MU-HF-BVD-01
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To prevent bleeding, hematoma, and embolism after coronary angiography, patients are asked to stay in bed for 6 to 24 hours. During complete bed rest for at least 6 hours, the patient should keep his/her feet flat. The patient should lie in the supine position and avoid rapid movements. Long-term bed rest (at least 6 hours) in post-angiographic patients causes weakening of the lower back muscles and fatigue due to the pressure constantly applied to the same muscles, while muscle fatigue causes muscle spasms and lower back pain. Today, acupressure is also used along with various pharmacological treatments to relieve pain and fatigue.

Acupressure is a massage technique that ensures the proper functioning of energy channels by applying some pressure to certain parts of the body with the thumbs or index fingers, hands, palms, wrists and knees for therapeutic purposes. Acupressure points are the same as acupuncture points. Although there is no needle inserted into the body as in acupuncture.

According to G-power analysis, the total number of samples was calculated as 120.

A total of 120 participants will be randomly assigned to the acupuncture group (n=40), sham acupuncture group (n=40) and control group (n=40).

A Personal Information Form and Visual Analog Scales for Pain and Fatigue will be used to collect data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,

Related Conditions & MeSH terms

• Back Pain
• Coronary Angiography
• Fatigue

Intervention

Other:
• Acupressure
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.
• Sham acupressure
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.

Locations

Country	Name	City	State
Turkey	Birgül VURAL DOGRU	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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