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Clinical Trials/NCT07691788
NCT07691788Active, not recruitingNot Applicable

Levels of Burnout and Well-Being Among Midwives: A Randomized Controlled Trial

KTO Karatay University1 site in 1 country90 target enrollmentStarted: July 2, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
Change in burnout level measured by the Maslach Burnout Inventory (MBI)

Study Overview

Brief Summary

This single-center, randomized controlled trial evaluates the effect of Therapeutic Touch on levels of burnout and psychological well-being among midwives who are actively working in a clinical setting. Participants are randomly allocated to one of three parallel groups: a Therapeutic Touch (intervention) group, a placebo/sham group, and a no-intervention control group. The investigators hypothesize that Therapeutic Touch will reduce burnout and improve psychological well-being compared with the placebo and control conditions.

Detailed Description

Background: Midwifery is a health discipline characterized by heavy workload and stressful clinical situations that require high levels of physical, emotional, and cognitive effort. Prolonged exposure to chronic stressors can lead to burnout, which negatively affects both the quality of midwifery care and midwives' general well-being. Therapeutic Touch (TT) is a non-invasive energy-field intervention aimed at balancing the individual's energy field. Evidence suggests that TT may reduce stress and anxiety, promote relaxation, and enhance overall well-being; however, studies directly examining its effect on the stress, burnout, and well-being of clinically working midwives are limited.

Objective: To evaluate the effectiveness of Therapeutic Touch in reducing burnout and improving general well-being among midwives working in a clinical setting.

Design: Single-center, single-blind, pretest-posttest, three-arm, randomized controlled experimental trial. The three arms are: (1) intervention group receiving Therapeutic Touch, (2) placebo/sham group, and (3) no-intervention control group.

Setting and Participants: The study population consists of midwives actively working at Elazig Fethi Sekin City Hospital.

Sample Size: The sample size will be calculated using G*Power 3.1.9.7 based on comparable studies, with a Type I error (alpha) of 0.05, power (1-beta) of 0.80, and the anticipated effect size. To account for possible dropouts, the sample size will be increased by 15-20%.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

Single-blind: the outcome assessor is blinded to group allocation.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Aged 18-65 years
  • Actively practicing midwifery in the field/clinic for at least one year
  • No prior energy therapy (Reiki, healing touch, Therapeutic Touch)
  • Literate and willing to volunteer for the study
  • Open to communication and cooperation

Exclusion Criteria

  • Currently being followed for a psychiatric diagnosis
  • Currently using antidepressant, anxiolytic, or sleep-regulating medication
  • Having touch sensitivity or a phobia-level aversion to being touched

Outcomes

Primary Outcomes

Change in burnout level measured by the Maslach Burnout Inventory (MBI)

Time Frame: Baseline (pretest) and after the 4-week intervention (posttest)

The Maslach Burnout Inventory is a 22-item, 5-point Likert scale with three subscales: emotional exhaustion (score range 0-36), depersonalization (0-20), and reduced personal accomplishment (0-32). Higher emotional exhaustion and depersonalization scores and lower personal accomplishment scores indicate greater burnout. Subscales are evaluated separately.

Change in psychological well-being measured by the Psychological Well-Being Scale (PWB)

Time Frame: Baseline (pretest) and after the 4-week intervention (posttest)

The Psychological Well-Being Scale (Diener flourishing short form) is an 8-item, 7-point Likert scale. Total scores range from 8 to 56, with higher scores indicating greater psychological resources and strengths.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
KTO Karatay University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aslıhan Turan

Principal Investigator

KTO Karatay University

Study Sites (1)

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