Clinical trial NCT05855473: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: intensive care nurses
acupuncture
fatigue
well-being
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from Baseline Fatigue at five weeks
timeFrame: Baseline, 5th week (after the intervention)
measure: Change from Baseline Energy Level at five weeks
timeFrame: Baseline, 5th week (after the intervention)
measure: Change from Baseline Well-being at five weeks
timeFrame: Baseline, 5th week (after the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University
Study officials:
References: