NCT07542691

Brief Summary

This study aims to evaluate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients after cardiac surgery. This randomized controlled trial will include 116 patients who will be randomly assigned to an intervention group or a control group. The intervention group will receive respiratory physiotherapy and progressive muscle relaxation exercises in addition to routine postoperative care for 30 minutes per day over three consecutive days, while the control group will receive routine care only. Outcome measures will include dyspnea assessed by the Modified Borg Scale, anxiety assessed by the State-Trait Anxiety Inventory, hemodynamic parameters obtained from vital signs, and delirium symptoms assessed using the Nursing Delirium Screening Scale. It is hypothesized that the combined intervention will reduce dyspnea and anxiety levels, improve hemodynamic stability, and decrease delirium symptoms. The findings are expected to contribute to improved postoperative recovery and reduced complication risks following cardiac surgery.

Trial Health

65
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Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started May 2026

Shorter than P25 for not_applicable

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 Progress21%
May 2026Jun 2026

First Submitted

Initial submission to the registry

April 9, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 9, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

Respiratory PhysiotherapyProgressive Muscle RelaxationCardiac RehabilitationPostoperative CareIntensive Care UnitHemodynamic Parameters

Outcome Measures

Primary Outcomes (1)

  • Dyspnea (Modified Borg Scale)

    Dyspnea severity will be assessed using the Modified Borg Scale (MBS). The scale ranges from 0 (no dyspnea) to 10 (maximal dyspnea). Higher scores indicate greater perceived breathlessness. Measurements will be performed by a trained assessor under standardized conditions.

    Within the first 24 hours after cardiac surgery (pre-intervention) and immediately after the intervention (post-intervention, same day)

Study Arms (2)

Routine Care

ACTIVE COMPARATOR

Participants in this group will receive routine postoperative care and standard cardiac rehabilitation without additional respiratory physiotherapy or progressive muscle relaxation exercises.

Other: Routine Care

Respiratory Physiotherapy + PMR

EXPERIMENTAL

Participants in this group will receive respiratory physiotherapy techniques, including breathing exercises, postural drainage, percussion, and vibration, combined with progressive muscle relaxation exercises in addition to routine postoperative care. The intervention will be applied for 30 minutes per day over three consecutive days following cardiac surgery.

Other: Respiratory PhysiotherapyOther: Progressive Muscle Relaxation

Interventions

Respiratory physiotherapy includes breathing exercises, postural drainage, percussion, and vibration techniques aimed at improving pulmonary function, facilitating secretion clearance, and enhancing oxygenation in postoperative cardiac surgery patients.

Respiratory Physiotherapy + PMR

Progressive muscle relaxation is a systematic technique involving sequential contraction and relaxation of muscle groups combined with controlled breathing, aimed at reducing anxiety, improving psychological well-being, and promoting physiological relaxation.

Respiratory Physiotherapy + PMR

Standard postoperative care and routine cardiac rehabilitation without additional respiratory physiotherapy or progressive muscle relaxation exercises.

Routine Care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 years who have undergone cardiac surgery
  • Hemodynamically stable patients
  • Patients able to cooperate and follow instructions
  • Patients with postoperative dyspnea
  • Patients who provide written informed consent

You may not qualify if:

  • Patients with severe cognitive impairment or inability to cooperate
  • Patients with neurological or psychiatric disorders affecting participation
  • Patients requiring mechanical ventilation for prolonged periods
  • Patients with unstable hemodynamic status
  • Patients with contraindications to respiratory physiotherapy or exercise
  • Patients who refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DyspneaAnxiety DisordersDelirium

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Fatma Cavdarcı, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to two parallel groups: an intervention group receiving respiratory physiotherapy and progressive muscle relaxation exercises in addition to routine care, and a control group receiving routine postoperative care only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 21, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. The study does not include a plan for sharing de-identified individual-level data due to institutional policies and ethical considerations.