Burnout, ProfessionalNCT07691788
Effect of Therapeutic Touch on Burnout and Well-Being in Midwives
A study testing Therapeutic Touch in people with Burnout, Professional and Psychological Well-Being, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Psychological Well-Being
- What is being tested?
- Therapeutic Touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levels of Burnout and Well-Being Among Midwives: A Randomized Controlled Trial
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.
Read the 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%.
Randomization and Blinding: Participants will be allocated to groups using block randomization or a computer-generated random number table. The trial is single-blind (outcome assessor blinded to group allocation).
Intervention Period: The intervention is delivered over a 4-week period.
Data Collection Tools: (1) Personal Information Form covering sociodemographic and occupational characteristics; (2) Maslach Burnout Inventory (MBI): a 22-item, 5-point Likert scale with three subscales (emotional exhaustion, depersonalization, and reduced personal accomplishment); (3) Psychological Well-Being Scale (PWB, Diener flourishing short form): an 8-item, 7-point Likert scale.
Withdrawal Criterion: Voluntary withdrawal from the study during the 4-week intervention period.
Statistical Analysis: Data will be analyzed with SPSS. After assessing distribution, descriptive statistics will be reported and between-group and within-group comparisons of the pretest and posttest scores will be performed using appropriate statistical tests for a three-arm randomized design. Statistical significance will be set at p < 0.05.
- Conditions
- Burnout, Professional, Psychological Well-Being
- Being tested
- Therapeutic Touch, Sham Therapeutic Touch
- Keywords
- Therapeutic Touch, Burnout, Well-Being, Midwives, Complementary Therapies, Energy Therapy
- Medical subject headings
- Burnout, Professional, Psychological Well-Being, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchBehavioural
Also called TT
A non-invasive energy-field intervention in which the practitioner uses the hands to detect and rebalance imbalances in the participant's energy field, delivered over a 4-week period.
Sham Therapeutic TouchBehavioural
A placebo/sham procedure resembling Therapeutic Touch but without the intended energy-field component, delivered over a 4-week period.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Touch | Experimental | Participants receive Therapeutic Touch, a non-invasive energy-field intervention, over a 4-week period. Receives: Behavioral: Therapeutic Touch |
| Placebo / Sham | Sham comparator | Participants receive a sham/placebo procedure that mimics Therapeutic Touch without the intended energy-field component, over a 4-week period. Receives: Behavioral: Sham Therapeutic Touch |
| Control | No intervention | Participants receive no intervention and continue their usual routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in burnout level measured by the Maslach Burnout Inventory (MBI)
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.
Measured: Baseline (pretest) and after the 4-week intervention (posttest)
Change in psychological well-being measured by the Psychological Well-Being Scale (PWB)
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.
Measured: Baseline (pretest) and after the 4-week intervention (posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start2 Jul 2026
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslıhan Turan, KTO Karatay University
- Investigators
- Aslihan Turan, PhD, Principal investigator, KTO Karatay UniversityBusra Karaaslan, Sub-investigator, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691788
- Sponsor's protocol ID
- KTOKaratay-Midwives-TT-2026
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels of Burnout and Well-Being Among Midwives: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07691788
- Acronym / sponsor ID
- KTOKaratay-Midwives-TT-2026
- Conditions
- Burnout, Professional, Psychological Well-Being
- Keywords
- Therapeutic Touch, Burnout, Well-Being, Midwives, Complementary Therapies, Energy Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Jul 2026 (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.
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%.
Randomization and Blinding: Participants will be allocated to groups using block randomization or a computer-generated random number table. The trial is single-blind (outcome assessor blinded to group allocation).
Intervention Period: The intervention is delivered over a 4-week period.
Data Collection Tools: (1) Personal Information Form covering sociodemographic and occupational characteristics; (2) Maslach Burnout Inventory (MBI): a 22-item, 5-point Likert scale with three subscales (emotional exhaustion, depersonalization, and reduced personal accomplishment); (3) Psychological Well-Being Scale (PWB, Diener flourishing short form): an 8-item, 7-point Likert scale.
Withdrawal Criterion: Voluntary withdrawal from the study during the 4-week intervention period.
Statistical Analysis: Data will be analyzed with SPSS. After assessing distribution, descriptive statistics will be reported and between-group and within-group comparisons of the pretest and posttest scores will be performed using appropriate statistical tests for a three-arm randomized design. Statistical significance will be set at p < 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Touch | Experimental | Behavioral: Therapeutic TouchParticipants receive Therapeutic Touch, a non-invasive energy-field intervention, over a 4-week period. |
| Placebo / Sham | Sham comparator | Behavioral: Sham Therapeutic TouchParticipants receive a sham/placebo procedure that mimics Therapeutic Touch without the intended energy-field component, over a 4-week period. |
| Control | No intervention | –Participants receive no intervention and continue their usual routine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Therapeutic TouchAlso: TTA non-invasive energy-field intervention in which the practitioner uses the hands to detect and rebalance imbalances in the participant's energy field, delivered over a 4-week period. | Behavioural | Therapeutic Touch |
| Sham Therapeutic TouchA placebo/sham procedure resembling Therapeutic Touch but without the intended energy-field component, delivered over a 4-week period. | Behavioural | Placebo / Sham |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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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.
Aslihan Turan, PhD principal investigator
KTO Karatay University
Busra Karaaslan sub-investigator
Elazıg Fethi Sekin Sehir Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Touch in people with Burnout, Professional and Psychological Well-Being, run by KTO Karatay 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 in burnout level measured by the Maslach Burnout Inventory (MBI) (time frame: Baseline (pretest) and after the 4-week intervention (posttest)). The study lists 2 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 9 Jul 2026.