The Effect on Back Pain and Fatigue Level of Acupressure

NCT ID: NCT06312397

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2024-08-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Angiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups ( acupressure group, sham acupressure group and control group)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Patients in the acupressure and sham acupressure groups were blinded as to which groups they were in.

Study Groups

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Acupressure group

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.

Group Type ACTIVE_COMPARATOR

Acupressure

Intervention Type OTHER

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.

Group Type PLACEBO_COMPARATOR

Sham acupressure

Intervention Type OTHER

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Birgul Vural Dogru

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Birgül VURAL DOĞRU

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Birgül VURAL DOĞRU, Associate Professor

Role: primary

03243610001

Other Identifiers

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MU-HF-BVD-01

Identifier Type: -

Identifier Source: org_study_id

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