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Clinical Trial NCT07090915 for Postoperative Stress is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The Influence of Natural Sounds on the Well-being of Patients After Orthopaedic Surgery 120

Not yet recruiting
Clinical Trial NCT07090915 is an interventional study for Postoperative Stress and is currently not yet recruiting. Enrollment is planned to begin on August 1, 2025 and continue until the study accrues 120 participants. Led by Michael Tobias Hirschmann, this study is expected to complete by June 1, 2026. The latest data from ClinicalTrials.gov was last updated on July 29, 2025.
Brief Summary
For many people, a stay in hospital can be associated with stress and anxiety, especially after surgery. In order to potentially make the stay more pleasant for patients in future, the investigators are conducting a study to investigate the use of natural sounds to promote relaxation. Participation in this study usually lasts until 3 days after the operation in hospital. If the participants decide to take part, the p...Show More
Official Title

Evaluating the Impact of Nature Soundscapes on Post-Operative Stress and Anxiety in Orthopedic Surgery Patients

Conditions
Postoperative Stress
Other Study IDs
  • 2025-01087
NCT ID Number
Start Date (Actual)
2025-08
Last Update Posted
2025-07-29
Completion Date (Estimated)
2026-06
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No Interventioncontrol group
standard hospital stay
N/A
ExperimentalIntervention group
nature sound
Modern audio technology is used to create a 3D natural atmosphere.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Depressions-Angst-Stress-Skalen (DASS-21)
0 to 63 (0 is best 63 is bad)
From the first day after surgery until the third day after surgery.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Relaxation State Questionnaire (RSQ), to measure the Relaxation
10 to 50 (10 is not relaxed, 50 is most relaxed)
From the first day after the surgery to the third day after the surgery.
NRS, to measure the Painlevel
0 to 10 (0 is no pain, 10 is most pain)
From the first day after the surgery to the third day after the surgery.
NRS, to measure the sleep quality
0 to 10 (0 is no sleep, 10 ist best sleep)
From the first day after the surgery to the third day after the surgery.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. duly completed declaration of consent
  2. the age of the patient is at least 18 years
  3. only patients undergoing orthopaedic surgery

  1. deafness
  2. severe cognitive impairment
  3. chronic pain patient
  4. pain catheter insertion during the trial period
  5. psychiatric disorders (e.g. anxiety disorders, depression, post-traumatic stress disorder, ...)
  6. severe postoperative complications
  7. no consent to participate
Michael Tobias Hirschmann logoMichael Tobias Hirschmann
Study Responsible Party
Michael Tobias Hirschmann, Sponsor-Investigator, Prof. Dr. med., Kantonsspital Baselland Bruderholz
Study Central Contact
Contact: Daniel Basic, 004161 400 60 89, [email protected]
1 Study Locations in 1 Countries

Bruderholz

Universitäres Zentrum Bewegungsapparat, Kantonsspital Baselland Bruderholz, Basel, Bruderholz, 4101, Germany
Daniel Basic, Contact, 004161 400 60 89, [email protected]