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Auricular Acupuncture on Fatigue, Energy and Well-Being in Intensive Care Nurses

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Auricular acupuncture
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring intensive care nurses, acupuncture, fatigue, well-being

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Working as a nurse in the intensive care unit for at least 6 months. No physical disability Those who do not have a neurological diagnosis (having SVO, epilepsy, multiplesclerosis, etc.) No psychiatric diagnosis On the ear skin at the application site; no lesions such as infection, ulcer, irritation, rash, scar and Nurses who volunteered to participate in the study Exclusion Criteria: Patients followed up with the diagnosis of end-stage renal disease, COPD, advanced heart failure, chronic liver disease, musculoskeletal problem, hypothyroidism and depression. Those who have physical and mental health problems that prevent communication Bleeding disorder or taking anticoagulant therapy pregnant Nurses who received any medical treatment or applied complementary methods (relaxation exercise, yoga, massage, etc.) during the study

Sites / Locations

  • Sakarya University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Semi-permanent needle

Seed

Control

Arm Description

Five sessions of unilateral auricular acupuncture were applied alternately to the right and left ears, once a week, to the intensive care nurses in the semi-permanent needle group. Semi-permanent needles placed on the acupuncture points of the nurses' ears remained for one week with adhesive tapes. In the sessions in the following weeks, semi-permanent needles were replaced with new ones. Shen men (TF4), Sympathetic (AH6a), Lung, Liver (CO12) Kidney point (CO10) were applied to five specific points in the ear in accordance with the NADA protocol.

Five sessions of unilateral auricular acupuncture were applied alternately to the right and left ears, once a week, to the intensive care nurses in the seed group. Seeds placed on the acupuncture points of the nurses' ears remained for one week with adhesive tapes. In the sessions in the following weeks, seeds were replaced with new ones. The seed group was asked to apply pressure on the bands three times a day, 15 times each time. Shen men (TF4), Sympathetic (AH6a), Lung, Liver (CO12) Kidney point (CO10) were applied to five specific points in the ear in accordance with the NADA protocol.

This group received no intervention.

Outcomes

Primary Outcome Measures

Change from Baseline Fatigue at five weeks
Chalder Fatigue Scale was used to evaluate the fatigue level of intensive care nurses. The scale consists of 11 items in total, including a 7-item physical fatigue subsection and a 4-item mental fatigue subsection. Participants are asked to answer the statements using a four-point Likert scale. Scoring is made between 0-3 and the total score varies between 0-33. High scores indicate greater fatigue severity.
Change from Baseline Energy Level at five weeks
Subjective Vitality Scale was used to evaluate the energy level of intensive care nurses. The scale, which is a 7-point Likert scale (1 strongly disagree-7 strongly agree), consists of seven items. The sum of the scores in the scale ranges from 7 to 49. High scores obtained from the scale indicate that the individual's subjective vitality level is high.
Change from Baseline Well-being at five weeks
Well-Being Scale was used to evaluate the well-being of intensive care nurses. Participants are expected to express their views on the scale items in a 7-point Likert-type rating ranging from 1-strongly disagree to 7-strongly agree. The highest score that can be obtained from the scale is 56, and the lowest score is 8. High scores obtained from the scale indicate that the level of well-being of the relevant individual is high.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2023
Last Updated
May 2, 2023
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT05855473
Brief Title
Auricular Acupuncture on Fatigue, Energy and Well-Being in Intensive Care Nurses
Official Title
Effects of Auricular Acupuncture on Fatigue, Energy, and Well-Being Among Intensive Care Nurses: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sakarya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Notably, no acupuncture intervention studies have aimed at reducing the fatigue level and increasing the energy of the nurses working in the ICU. For this reason, this study aims to investigate the effects of auricular acupuncture applied to nurses working in the ICU, who work at a critical point in patient care in our country, work with intense work tempo, experience excessive stress, tension, fatigue, and are open to psychosocial problems such as depression and burnout, on fatigue and energy levels. This study can significantly contribute to the literature on managing the physical and psychosocial issues associated with fatigue and that similar intervention programs can be expanded in working life. This study aimed to determine the effect of auricular acupuncture applied to intensive care nurses on fatigue, energy and well-being. This was a single-blind, randomized controlled clinical study. The study was conducted in three groups: semi-permanent needle acupuncture (intervention), seed acupuncture (intervention), and a control group.
Detailed Description
A stratified randomization method was used to determine intervention, placebo and control groups. It was ensured that the nurses were evenly distributed to the groups according to their age, working year and baseline fatigue scores. A computer-generated (https://www.randomizer.org/) sorting was used to allocate the groups homogeneously. The intervention groups received five sessions of auricular acupuncture with semi-permanent needles and seeds once a week. Semi-permanent needles and seeds placed in nurses' ear acupuncture points stayed for one week. In the sessions in the following weeks, semi-permanent needles and seeds were replaced with new ones. Nurses were reminded to remove the semi-permanent needle and seed tapes 24 hours before the scheduled session. They are also instructed to remove it beforehand if there is any discomfort, itching or any sign of allergy. Placement of the semi-permanent needles and seed tapes took approximately five minutes per session. Before each session for the semi-permanent needle group, the ears of the participants were cleaned with a 70% alcohol wipe and sterile, fine-caliber, disposable semi-permanent needles were used. A similar application was made to the seed group and they were asked to apply pressure on the bands three times a day, 15 times each time. These were placed unilaterally on five specific points in the ear (ShenMen, sympathetic, liver, kidney, lung) by a certified specialist in acupuncture using the National Acupuncture Detoxification Association (NADA) protocol. Since the body or organs have an emotional component and can be adversely affected by excessive and prolonged emotions, these ear points were chosen to facilitate the release of negative/toxic emotions from the organs. This process was thought to help the treated participant return to balance and increase energy and well-being by giving a feeling of calm instead of stress and anxiety. Shen men (TF4) and Sympathetic (AH6a) points can regulate the sympathetic and parasympathetic nervous systems to effectively reduce patient tension and anxiety. In addition, the TF4 point reduces anxiety, while the AH6a point calms excessive sympathetic activity. Both of these points help increase parasympathetic activation by balancing the sympathetic/parasympathetic branches of the autonomic nervous system. Low mood and lethargy are improved by stimulating the liver (CO12). Kidney point (CO10) is a point that has a strengthening effect by relieving mental weakness, fatigue and headaches and stimulating kidney functions. Combining these ear acupuncture points can increase the energy and blood flow of the organs, thereby relieving the patient's fatigue. Data were collected at baseline and at the end of the intervention (week 5) using the Chalder Fatigue Scale, Subjective Vitality Scale, and Well-being Scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
intensive care nurses, acupuncture, fatigue, well-being

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semi-permanent needle
Arm Type
Experimental
Arm Description
Five sessions of unilateral auricular acupuncture were applied alternately to the right and left ears, once a week, to the intensive care nurses in the semi-permanent needle group. Semi-permanent needles placed on the acupuncture points of the nurses' ears remained for one week with adhesive tapes. In the sessions in the following weeks, semi-permanent needles were replaced with new ones. Shen men (TF4), Sympathetic (AH6a), Lung, Liver (CO12) Kidney point (CO10) were applied to five specific points in the ear in accordance with the NADA protocol.
Arm Title
Seed
Arm Type
Experimental
Arm Description
Five sessions of unilateral auricular acupuncture were applied alternately to the right and left ears, once a week, to the intensive care nurses in the seed group. Seeds placed on the acupuncture points of the nurses' ears remained for one week with adhesive tapes. In the sessions in the following weeks, seeds were replaced with new ones. The seed group was asked to apply pressure on the bands three times a day, 15 times each time. Shen men (TF4), Sympathetic (AH6a), Lung, Liver (CO12) Kidney point (CO10) were applied to five specific points in the ear in accordance with the NADA protocol.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group received no intervention.
Intervention Type
Other
Intervention Name(s)
Auricular acupuncture
Intervention Description
The NADA protocol used in this study uses five specific points on the ear: Shen men, sympathetic autonomic, lung, liver, and kidney. Using this protocol, semi-permanent needles and seeds were placed unilaterally at five specific points in the ear by a specialist physician certified in acupuncture.
Primary Outcome Measure Information:
Title
Change from Baseline Fatigue at five weeks
Description
Chalder Fatigue Scale was used to evaluate the fatigue level of intensive care nurses. The scale consists of 11 items in total, including a 7-item physical fatigue subsection and a 4-item mental fatigue subsection. Participants are asked to answer the statements using a four-point Likert scale. Scoring is made between 0-3 and the total score varies between 0-33. High scores indicate greater fatigue severity.
Time Frame
Baseline, 5th week (after the intervention)
Title
Change from Baseline Energy Level at five weeks
Description
Subjective Vitality Scale was used to evaluate the energy level of intensive care nurses. The scale, which is a 7-point Likert scale (1 strongly disagree-7 strongly agree), consists of seven items. The sum of the scores in the scale ranges from 7 to 49. High scores obtained from the scale indicate that the individual's subjective vitality level is high.
Time Frame
Baseline, 5th week (after the intervention)
Title
Change from Baseline Well-being at five weeks
Description
Well-Being Scale was used to evaluate the well-being of intensive care nurses. Participants are expected to express their views on the scale items in a 7-point Likert-type rating ranging from 1-strongly disagree to 7-strongly agree. The highest score that can be obtained from the scale is 56, and the lowest score is 8. High scores obtained from the scale indicate that the level of well-being of the relevant individual is high.
Time Frame
Baseline, 5th week (after the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Working as a nurse in the intensive care unit for at least 6 months. No physical disability Those who do not have a neurological diagnosis (having SVO, epilepsy, multiplesclerosis, etc.) No psychiatric diagnosis On the ear skin at the application site; no lesions such as infection, ulcer, irritation, rash, scar and Nurses who volunteered to participate in the study Exclusion Criteria: Patients followed up with the diagnosis of end-stage renal disease, COPD, advanced heart failure, chronic liver disease, musculoskeletal problem, hypothyroidism and depression. Those who have physical and mental health problems that prevent communication Bleeding disorder or taking anticoagulant therapy pregnant Nurses who received any medical treatment or applied complementary methods (relaxation exercise, yoga, massage, etc.) during the study
Facility Information:
Facility Name
Sakarya University
City
Sakarya
ZIP/Postal Code
54050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Auricular Acupuncture on Fatigue, Energy and Well-Being in Intensive Care Nurses

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