Diaphragmatic and Box Breathing on Heart Rate Variability and Perceived Stress (HRV DB BB PSS)

July 13, 2026 updated by: Alaa Naseer Abdelhameed Abdelmohsen, Cairo University

Enhancing Physiological and Psychological Resilience: A Comparative Study of Diaphragmatic and Box Breathing in Physical Therapy Students.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Challenge: Stress in Healthcare Education University life is a demanding transitional period, and students training in healthcare fields like physical therapy often face immense academic and clinical pressures. Research shows that up to 50.1% of physiotherapy students experience high levels of stress, which can surge even higher during their hands-on clinical rotations. This stress is more than just an emotional burden; it actively impairs working memory, reduces attention span, and often leads to lower grades and poorer overall academic performance.

The Goal of the Study This study aims to discover if simple, accessible breathing exercises can help undergraduate physical therapy students build resilience and better manage their stress. Specifically, the research will compare the effectiveness of two distinct breathing techniques-diaphragmatic breathing and box breathing-to see how they impact both the mind (psychological stress and cognition) and the body (physiological adaptation).

How the Study Works The study will involve 60 undergraduate physical therapy students from Deraya University who are currently experiencing moderate to high levels of academic stress. These participants will be randomly divided into three equal groups: The Diaphragmatic Breathing Group: Participants will practice a relaxing, slow-paced breathing pattern. They will inhale through the nose for 4 seconds and exhale through the mouth for 6 seconds, focusing on expanding their abdomen. The Box Breathing Group: Participants will practice a structured technique often used in high-stress tactical environments to enhance stress tolerance. It involves a "4-4-4-4" cycle: inhaling for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding the breath out for 4 seconds. The Control Group: Participants will simply continue their normal daily routines without any specific breathing interventions so researchers have a baseline for comparison. The two breathing groups will practice their designated techniques for 15 minutes a day, 6 days a week, over a 4-week period. What is Being Measured?To accurately determine if these techniques work, the study will evaluate several key areas:Heart Rate Variability (HRV): Using a highly accurate chest strap sensor (the Polar H10), researchers will measure the subtle variations in time between heartbeats. HRV is a primary indicator of how well the nervous system is regulating stress and keeping the body balanced. Stress and Resilience: Participants will complete standardized questionnaires to evaluate their perceived stress levels and their ability to "bounce back" from daily challenges. Cognitive and Academic Performance: The study will use specialized cognitive tests (like the Stroop Color-Word Test) to measure attention and executive functioning. It will also evaluate the students' confidence in their ability to manage time, prepare for exams, and succeed academically.

Why This Matters Because academic stress is incredibly prevalent among health sciences students, finding practical, non-medication-based ways to support their mental health is critical. By comparing these two breathing methods, this study hopes to identify an effective, non-invasive tool that students can easily use to lower their anxiety, improve their focus, and ultimately thrive in their demanding academic and clinical environments.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alaa N Abdelhameed Abdelmohsen, B.Sc. in Physical Therapy
  • Phone Number: +201061382864
  • Email: alaa.nasser@deraya.edu.eg

Study Contact Backup

Study Locations

  • Egypt
    • Minya Province
      • Minya, Minya Province, Egypt
        • Faculty of Physical Therapy, Deraya University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Behavioral: Diaphramatic Breathing Training

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
Experimental: 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 Sessions will last 15 minutes, 6 sessions/week, for 4 weeks
Behavioral: Box Breathing Training

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
No Intervention: Control Group
Participants will continue their normal daily routines and will not receive any breathing intervention during the study period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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
Time Frame: Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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
Time Frame: Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive Performance
Time Frame: Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
Cognitive performance will be assessed using the Stroop Color-Word Test. The score represents the number of correct responses. The minimum possible score is 0, with no strictly defined maximum. Higher scores indicate better cognitive performance, representing a better outcome
Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
Academic Achievement
Time Frame: Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
Academic achievement will be assessed using the 9-item Academic Self-Efficacy Scale (ASE). The total score ranges from a minimum of 9 to a maximum of 63. Higher scores indicate higher levels of academic self-efficacy, representing a better outcome
Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Rana H Elbanaa, Assoiate Professor, Cairo University
  • Study Director: Fatma Y Abdelsalam, Lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CU-AN-19052026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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