Enhancing Autonomic Regulation and Attention Through Biofeedback in Female Athletes

NCT07061834 | Completed

• 1 other identifier: KMU_SBF-YM-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the impact of a multimodal biofeedback intervention on autonomic function and sustained attention in female volleyball players.

Conditions

Psychological Aspects; Skin Temperature Change; Biofeedback Training; Volleyball Players; Autonomic Regulation

Keywords

Skin Conductance; biofeedback; mental health; attention; galvanic skin response

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 5 weeks"

Secondary Outcomes (2)

• Galvanic Skin Response

  From enrollment to the end of treatment at 5 weeks.

• Peripheral Temperature

  From enrollment to the end of treatment at 5 weeks.

Study Arms (2)

Biofeedback group

EXPERIMENTAL

The BFB group completed 15 sessions of multimodal BFB training over five weeks.

Device: Biofeedback training; Other: control group

Control group

NO INTERVENTION

The control group received no intervention.

Interventions

Biofeedback training DEVICE

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.

Also known as: Multimodal biofeedback

Biofeedback group

control group OTHER

The control group received no intervention.

Also known as: non intervention group

Biofeedback group

Eligibility Criteria

• Age: 17 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Good general health
• Nonsmoking status
• A history of regular menstrual cycles
• No mental, neurological, or cardiovascular disorders
• Active participation in national volleyball tournaments

You may not qualify if:

• Use of illegal substances, oral contraceptives, antidepressants
• Consuming alcohol or drugs
• Current psychotherapy
• A history of BFB intervention

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Faculty of Sports Sciences

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 41013699 DERIVED

Related Links

• pubmed page

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yücel Makaracı Makaracı, PhD

  Karamanoğlu Mehmetbey University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study did not implement blinding or masking procedures for participants, investigators, or outcome assessors. Participants in both groups continued their regular volleyball training schedules; however, only the intervention group received the additional biofeedback training. The control group did not receive any specific treatment during the intervention period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: a parallel-group interventional design (biofeedback and control)

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 11, 2025
• Study Start: August 1, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 30, 2023
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)