FatigueNCT05855473
Auricular Acupuncture on Fatigue, Energy and Well-Being in Intensive Care Nurses
A study testing Auricular acupuncture in people with Fatigue, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Auricular acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Auricular Acupuncture on Fatigue, Energy, and Well-Being Among Intensive Care Nurses: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Fatigue
- Being tested
- Auricular acupuncture
- Keywords
- intensive care nurses, acupuncture, fatigue, well-being
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Semi-permanent needle | Experimental | 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. Receives: Other: Auricular acupuncture |
| Seed | Experimental | 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. Receives: Other: Auricular acupuncture |
| Control | No intervention | This group received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 5th week (after the intervention)
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.
Measured: Baseline, 5th week (after the intervention)
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.
Measured: Baseline, 5th week (after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start15 Dec 2022
- Primary completion15 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva SERT, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855473
- Sponsor's protocol ID
- 45/08.06.2022
- Status last verified
- May 2023
- First submitted
- 6 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Auricular Acupuncture on Fatigue, Energy, and Well-Being Among Intensive Care Nurses: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05855473
- Acronym / sponsor ID
- 45/08.06.2022
- Conditions
- Fatigue
- Keywords
- intensive care nurses, acupuncture, fatigue, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semi-permanent needle | Experimental | Other: Auricular acupunctureFive 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. |
| Seed | Experimental | Other: Auricular acupunctureFive 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. |
| Control | No intervention | –This group received no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupunctureThe 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. | Other | Seed, Semi-permanent needle |
Primary outcome
Change from Baseline Fatigue at five weeks
Time frame: Baseline, 5th week (after the intervention)
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
Time frame: Baseline, 5th week (after the intervention)
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
Time frame: Baseline, 5th week (after the intervention)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupuncture in people with Fatigue, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Fatigue at five weeks (time frame: Baseline, 5th week (after the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.