Psychological AspectsNCT07061834
Enhancing Autonomic Regulation and Attention Through Biofeedback in Female Athletes
A study testing Biofeedback training in people with Psychological Aspects and Skin Temperature Change, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the impact of a multimodal biofeedback intervention on autonomic function and sustained attention in female volleyball players. Read more about this study
- Who is it for?
- Ages 17 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Aspects, Skin Temperature Change, Biofeedback Training
- What is being tested?
- Biofeedback training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 30 Sep 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 17 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Good general health
- Nonsmoking status
- A history of regular menstrual cycles
- No mental, neurological, or cardiovascular disorders
- Active participation in national volleyball tournaments
Who cannot join
- Use of illegal substances, oral contraceptives, antidepressants
- Consuming alcohol or drugs
- Current psychotherapy
- A history of BFB intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Autonomic Regulation and Attention Through Galvanic Skin Response and Peripheral Temperature Biofeedback in Female Volleyball Players: a Randomized Pilot Trial
This study aimed to evaluate the impact of a multimodal biofeedback intervention on autonomic function and sustained attention in female volleyball players.
Read the detailed description
Optimal performance in elite athletes is shaped by a combination of physical preparedness and psychological readiness, where managing stress and anxiety is as critical as enhancing physical capabilities. Competitive anxiety can disrupt cognitive functioning, attention, and decision-making, affecting athletes' composure and overall performance. Cognitive abilities such as attentional control, mental flexibility, and perceptual-motor coordination are vital during high-pressure moments in sports, especially team sports like volleyball. Emerging approaches in applied sports psychology have started using biofeedback (BFB) to address these psychological and cognitive demands. BFB enables athletes to consciously regulate physiological responses associated with stress, such as heart rate variability (HRV), galvanic skin response (GSR), peripheral temperature (PT), and muscle activity, by providing real-time feedback. These interventions aim to enhance autonomic control, emotional regulation, and ultimately, cognitive performance.
Multimodal BFB interventions that simultaneously target several physiological parameters are gaining attention for their potential to support mental readiness and attentional performance in athletes. However, the application of such protocols in team sports remains underexplored. Given the high cognitive demands of volleyball, especially in sustained attention and rapid decision-making under pressure, there is a need to examine whether multimodal BFB can produce meaningful improvements in these areas. This study investigated the effects of a five-week, 15-session multimodal BFB intervention on sustained attention and physiological responses in competitive female volleyball players. It was hypothesized that the intervention would lead to measurable physiological changes-specifically a reduction in GSR and an increase in PT-which in turn would support improved cognitive performance in the form of enhanced sustained attention.
- Conditions
- Psychological Aspects, Skin Temperature Change, Biofeedback Training, Volleyball Players, Autonomic Regulation
- Being tested
- Biofeedback training, control group
- Keywords
- Skin Conductance, biofeedback, mental health, attention, galvanic skin response
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback trainingDevice
Also called Multimodal biofeedback
The intervention consists of biofeedback training using the Nexus 10 device, which provides real-time feedback on physiological signals including galvanic skin response and peripheral temperature. Participants undergo sessions where they learn to consciously regulate their autonomic nervous system activity by observing and modifying these signals. This training aims to improve stress regulation and enhance physiological self-control. Unlike other biofeedback interventions, this protocol focuses on combined skin conductance and temperature measures delivered through the Nexus 10 system over multiple sessions.
control groupOther
Also called non intervention group
The control group received no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback group | Experimental | The BFB group completed 15 sessions of multimodal BFB training over five weeks. Receives: Device: Biofeedback training; Other: control group |
| Control group | No intervention | The control group received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention
Sustained Attention in this study was assessed using the d2 Test of Attention, a standardized paper-and-pencil test designed to measure an individual's ability to maintain focused and selective attention over a continuous period. During the test, participants were required to scan rows of letters and quickly identify and mark the target letter "d" with two dashes, while ignoring similar distracting stimuli. The test evaluates concentration, processing speed, and the ability to sustain attention under time pressure. Performance is quantified by the number of correctly identified targets minus errors, reflecting how effectively the participant can sustain attention and resist distractions throughout the task.
Measured: From enrollment to the end of treatment at 5 weeks"
Secondary outcomes (2)
Galvanic Skin Response
Galvanic Skin Response (GSR) refers to changes in the skin's electrical conductance, which vary with sweat gland activity and are linked to physiological arousal and emotional states. In this study, GSR was measured as a secondary outcome using biofeedback training with the Nexus 10 device, a system that records real-time skin conductance data through sensors placed on the participant's fingers. This measurement reflects the participant's autonomic nervous system activity, providing insight into stress levels, emotional regulation, and overall physiological responses during the biofeedback sessions.
Measured: From enrollment to the end of treatment at 5 weeks.
Peripheral Temperature
Peripheral Temperature refers to the temperature of the skin on the extremities, such as fingers or toes, which can indicate changes in blood flow and autonomic nervous system activity. In this study, peripheral temperature was measured as a secondary outcome using the Nexus 10 device during biofeedback training. Sensors placed on the participant's fingers recorded skin temperature continuously, providing information about physiological responses related to relaxation, stress, and circulation.
Measured: From enrollment to the end of treatment at 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Aug 2023
- Primary completion15 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological AspectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a parallel-group interventional design (biofeedback and control)
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yucel Makaraci, Karamanoğlu Mehmetbey University
- Investigators
- Yücel Makaracı Makaracı, PhD, Study director, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061834
- Sponsor's protocol ID
- KMU_SBF-YM-01
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant privacy and because consent did not cover data sharing beyond the research team.
Publications
Makaraci M, Makaraci Y. Enhancing autonomic regulation and attention through galvanic skin response and peripheral temperature biofeedback in female volleyball players: a randomized pilot trial. BMC Sports Sci Med Rehabil. 2025 Sep 26;17(1):274. doi: 10.1186/s13102-025-01344-7.
PubMed 41013699
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Autonomic Regulation and Attention Through Galvanic Skin Response and Peripheral Temperature Biofeedback in Female Volleyball Players: a Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT07061834
- Acronym / sponsor ID
- KMU_SBF-YM-01
- Conditions
- Psychological Aspects, Skin Temperature Change, Biofeedback Training, Volleyball Players, Autonomic Regulation
- Keywords
- Skin Conductance, biofeedback, mental health, attention, galvanic skin response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 11 Jul 2025 (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 study aimed to evaluate the impact of a multimodal biofeedback intervention on autonomic function and sustained attention in female volleyball players.
Detailed description
Optimal performance in elite athletes is shaped by a combination of physical preparedness and psychological readiness, where managing stress and anxiety is as critical as enhancing physical capabilities. Competitive anxiety can disrupt cognitive functioning, attention, and decision-making, affecting athletes' composure and overall performance. Cognitive abilities such as attentional control, mental flexibility, and perceptual-motor coordination are vital during high-pressure moments in sports, especially team sports like volleyball. Emerging approaches in applied sports psychology have started using biofeedback (BFB) to address these psychological and cognitive demands. BFB enables athletes to consciously regulate physiological responses associated with stress, such as heart rate variability (HRV), galvanic skin response (GSR), peripheral temperature (PT), and muscle activity, by providing real-time feedback. These interventions aim to enhance autonomic control, emotional regulation, and ultimately, cognitive performance.
Multimodal BFB interventions that simultaneously target several physiological parameters are gaining attention for their potential to support mental readiness and attentional performance in athletes. However, the application of such protocols in team sports remains underexplored. Given the high cognitive demands of volleyball, especially in sustained attention and rapid decision-making under pressure, there is a need to examine whether multimodal BFB can produce meaningful improvements in these areas. This study investigated the effects of a five-week, 15-session multimodal BFB intervention on sustained attention and physiological responses in competitive female volleyball players. It was hypothesized that the intervention would lead to measurable physiological changes-specifically a reduction in GSR and an increase in PT-which in turn would support improved cognitive performance in the form of enhanced sustained attention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a parallel-group interventional design (biofeedback and control)
| Arm | Type | Receives |
|---|---|---|
| Biofeedback group | Experimental | Device: Biofeedback training, Other: control groupThe BFB group completed 15 sessions of multimodal BFB training over five weeks. |
| Control group | No intervention | –The control group received no intervention. |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Good general health
- Nonsmoking status
- A history of regular menstrual cycles
- No mental, neurological, or cardiovascular disorders
- Active participation in national volleyball tournaments
Key exclusion criteria (4 listed)
- Use of illegal substances, oral contraceptives, antidepressants
- Consuming alcohol or drugs
- Current psychotherapy
- A history of BFB intervention
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 |
|---|---|---|
| Biofeedback trainingAlso: Multimodal biofeedbackThe intervention consists of biofeedback training using the Nexus 10 device, which provides real-time feedback on physiological signals including galvanic skin response and peripheral temperature. Participants undergo sessions where they learn to consciously regulate their autonomic nervous system activity by observing and modifying these signals. This training aims to improve stress regulation and enhance physiological self-control. Unlike other biofeedback interventions, this protocol focuses on combined skin conductance and temperature measures delivered through the Nexus 10 system over multiple sessions. | Device | Biofeedback group |
| control groupAlso: non intervention groupThe control group received no intervention. | Other | Biofeedback group |
Primary outcome
Attention
Time frame: From enrollment to the end of treatment at 5 weeks"
Sustained Attention in this study was assessed using the d2 Test of Attention, a standardized paper-and-pencil test designed to measure an individual's ability to maintain focused and selective attention over a continuous period. During the test, participants were required to scan rows of letters and quickly identify and mark the target letter "d" with two dashes, while ignoring similar distracting stimuli. The test evaluates concentration, processing speed, and the ability to sustain attention under time pressure. Performance is quantified by the number of correctly identified targets minus errors, reflecting how effectively the participant can sustain attention and resist distractions throughout the task.
2 secondary outcomes
Galvanic Skin Response
Time frame: From enrollment to the end of treatment at 5 weeks.
Peripheral Temperature
Time frame: From enrollment to the end of treatment at 5 weeks.
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 Jul 2025.
- Derived from this study: PubMed 41013699Makaraci M, Makaraci Y. Enhancing autonomic regulation and attention through galvanic skin response and peripheral temperature biofeedback in female volleyball players: a randomized pilot trial. BMC Sports Sci Med Rehabil. 2025 Sep 26;17(1):274. doi: 10.1186/s13102-025-01344-7.
- pubmed pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant privacy and because consent did not cover data sharing beyond the research team.
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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.
Yücel Makaracı Makaracı, PhD study director
Karamanoğlu Mehmetbey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback training in people with Psychological Aspects and Skin Temperature Change, run by Karamanoğlu Mehmetbey 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 4 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 Jul 2025. 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?
Attention (time frame: From enrollment to the end of treatment at 5 weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07061834, which also lists 1 linked publication.
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 Jul 2025.