NCT05855473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

April 6, 2023

Last Update Submit

May 2, 2023

Conditions

Keywords

intensive care nursesacupuncturefatiguewell-being

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline, 5th week (after the intervention)

Study Arms (3)

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.

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.

Other: Auricular acupuncture

Control

NO INTERVENTION

This group received no intervention.

Interventions

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.

SeedSemi-permanent needle

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, 54050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2023

First Posted

May 11, 2023

Study Start

December 15, 2022

Primary Completion

March 15, 2023

Study Completion

March 30, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations