NCT07698652

Brief Summary

The goal of this clinical trial is to learn if diaphragmatic breathing and box breathing work to enhance resilience and manage stress in physical therapy students. It will also learn about their effects on overall physiological and psychological parameters. The main questions it aims to answer are: Do these breathing techniques improve heart rate variability (HRV)? How do these interventions affect participants' perceived stress levels, cognitive performance, and academic achievement? Researchers will compare diaphragmatic breathing and box breathing to a control group to see if these non-invasive methods work to improve physiological adaptation and manage stress. Participants will: Be randomly assigned to practice diaphragmatic breathing, practice box breathing, or join a control group Have their heart rate variability (HRV) measured as a primary sign of physiological adaptation Complete assessments to evaluate their perceived stress, cognitive performance, and academic achievement

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress14%
Jul 2026Mar 2027

Study Start

First participant enrolled

July 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 7, 2026

Last Update Submit

July 13, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Heart Rate Variability

    HRV will be measured using the Polar H10 sensor and analyzed through Kubios HRV software to evaluate physiological resilience and autonomic nervous system regulation.

    Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).

  • Perceived Stress

    Stress will be measured using the Perceived Stress Scale (PSS-10). The total score ranges from a minimum of 0 to a maximum of 40. Higher scores indicate higher levels of perceived stress, representing a worse outcome

    Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).

  • Resilience

    Resilience will be measured using the Brief Resilience Scale (BRS). The score ranges from a minimum of 1 to a maximum of 5. Higher scores indicate higher levels of resilience, representing a better outcome

    Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).

Secondary Outcomes (2)

  • Cognitive Performance

    Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).

  • Academic Achievement

    Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).

Study Arms (3)

Diaphragmatic Breathing Group

EXPERIMENTAL

Participants will sit comfortably with their hands in their abdomen. They will: * Inhale through the nose for 4 seconds * Exhale through the mouth for 6 seconds * Focus on abdominal expansion and relaxation * Continue for 15 minutes, 6 sessions/week, for 4 weeks

Behavioral: Diaphramatic Breathing Training

Box Breathing Group

EXPERIMENTAL

Participants will perform a structured breath cycle: * Inhale for 4 seconds * Hold for 4 seconds * Exhale for 4 seconds * Hold for 4 seconds Sessions will last 15 minutes, 6 sessions/week, for 4 weeks

Behavioral: Box Breathing Training

Control Group

NO INTERVENTION

Participants will continue their normal daily routines and will not receive any breathing intervention during the study period

Interventions

Diaphragmatic Breathing Group: Participants will sit comfortably with their hands in their abdomen. They will: * Inhale through the nose for 4 seconds * Exhale through the mouth for 6 seconds * Focus on abdominal expansion and relaxation * Continue for 15 minutes, 6 sessions/week, for 4 weeks

Diaphragmatic Breathing Group

Box Breathing Group: Participants will perform a structured breath cycle: * Inhale for 4 seconds * Hold for 4 seconds * Exhale for 4 seconds * Hold for 4 seconds

Box Breathing Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Academic Status: Currently enrolled, full-time undergraduate Physical Therapy students
  • Age Range: 18-25 years
  • Health Status: Generally healthy individuals with no known chronic respiratory or cardiovascular diseases.
  • Informed Consent: Ability and willingness to provide written informed consent and commit to the 4-week protocol (6 sessions/week).
  • Stress Level: A baseline score on the Perceived Stress Scale (PSS) indicating at least moderate stress.

You may not qualify if:

  • Pre-existing Breathing Expertise: Individuals with professional training in yoga (Pranayama), formal meditation, or advanced breath work that might bias the baseline results.
  • Medical Conditions: Diagnosed respiratory conditions (e.g., Asthma, COPD).
  • Cardiovascular issues (e.g., Arrhythmias, Hypertension).
  • Clinical psychological disorders (e.g., Generalized Anxiety Disorder or Panic Disorder) that may require medication.
  • Pharmacological Factors: Use of medications that influence the Autonomic Nervous System (e.g., Beta-blockers, antidepressants, or heavy use of stimulants/sedatives).
  • Substance Use: Smokers/Vapers
  • Excessive Caffeine "Participants consuming more than 400 mg of caffeine per day (equivalent to approximately 4 standard cups of brewed coffee) will be excluded.
  • Recent Acute Illness: Any respiratory tract infection or fever within two weeks prior to the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Deraya University

Minya, Minya Province, Egypt

Location

Study Officials

  • Rana H Elbanaa, Assoiate Professor

    Cairo University

    STUDY CHAIR
  • Fatma Y Abdelsalam, Lecturer

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Alaa N Abdelhameed Abdelmohsen, B.Sc. in Physical Therapy

CONTACT

Abdelrahman A Mohamed, B.Sc. in Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to maintain participant privacy and strictly adhere to confidentiality agreements.

Locations