Postoperative StressNCT07090915
The Influence of Natural Sounds on the Well-being of Patients After Orthopaedic Surgery
A study testing nature sound in people with Postoperative Stress, run by Michael Tobias Hirschmann at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Stress
- What is being tested?
- nature sound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- duly completed declaration of consent
- the age of the patient is at least 18 years
- only patients undergoing orthopaedic surgery
Who cannot join
- deafness
- severe cognitive impairment
- chronic pain patient
- pain catheter insertion during the trial period
- psychiatric disorders (e.g. anxiety disorders, depression, post-traumatic stress disorder, ...)
- severe postoperative complications
- no consent to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Universitäres Zentrum Bewegungsapparat, Kantonsspital Baselland Bruderholz
Basel, Bruderholz, 4101
Daniel Basic, 004161 400 60 89, daniel.basic@ksbl.ch
About this study
Official title: Evaluating the Impact of Nature Soundscapes on Post-Operative Stress and Anxiety in Orthopedic Surgery Patients
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 participants will be randomly assigned to one of two groups: The intervention group or the control group. In the intervention group, the participants will listen to different natural sounds twice a day. In the control group, the participants will not receive any nature sounds. During the stay, the participants will be given two questionnaires to fill in about how you feel. Participants assigned to the intervention group will additionallyreceive a short telephone interview 14 days after the operation.
- Conditions
- Postoperative Stress
- Being tested
- nature sound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nature soundOther
Modern audio technology is used to create a 3D natural atmosphere.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | standard hospital stay |
| Intervention group | Experimental | Not described Receives: Other: nature sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressions-Angst-Stress-Skalen (DASS-21)
0 to 63 (0 is best 63 is bad)
Measured: From the first day after surgery until the third day after surgery.
Secondary outcomes (3)
Relaxation State Questionnaire (RSQ), to measure the Relaxation
10 to 50 (10 is not relaxed, 50 is most relaxed)
Measured: 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)
Measured: 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)
Measured: From the first day after the surgery to the third day after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Tobias Hirschmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Tobias Hirschmann, Kantonsspital Baselland Bruderholz
- Investigators
- Michael Hirschmann, Prof. Dr. med., Principal investigator, Universitäres Zentrum Bewegungsapparat, Kantonsspital Baselland Bruderholz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090915
- Sponsor's protocol ID
- 2025-01087
- Other IDs
- 2025
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Nature Soundscapes on Post-Operative Stress and Anxiety in Orthopedic Surgery Patients
- ClinicalTrials.gov ID
- NCT07090915
- Acronym / sponsor ID
- 2025-01087
- Conditions
- Postoperative Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Michael Tobias HirschmannUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 participants will be randomly assigned to one of two groups: The intervention group or the control group. In the intervention group, the participants will listen to different natural sounds twice a day. In the control group, the participants will not receive any nature sounds. During the stay, the participants will be given two questionnaires to fill in about how you feel. Participants assigned to the intervention group will additionallyreceive a short telephone interview 14 days after the operation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –standard hospital stay |
| Intervention group | Experimental | Other: nature sound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- duly completed declaration of consent
- the age of the patient is at least 18 years
- only patients undergoing orthopaedic surgery
Key exclusion criteria (7 listed)
- deafness
- severe cognitive impairment
- chronic pain patient
- pain catheter insertion during the trial period
- psychiatric disorders (e.g. anxiety disorders, depression, post-traumatic stress disorder, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nature soundModern audio technology is used to create a 3D natural atmosphere. | Other | Intervention group |
Primary outcome
Depressions-Angst-Stress-Skalen (DASS-21)
Time frame: From the first day after surgery until the third day after surgery.
0 to 63 (0 is best 63 is bad)
3 secondary outcomes
Relaxation State Questionnaire (RSQ), to measure the Relaxation
Time frame: From the first day after the surgery to the third day after the surgery.
NRS, to measure the Painlevel
Time frame: From the first day after the surgery to the third day after the surgery.
NRS, to measure the sleep quality
Time frame: From the first day after the surgery to the third day after the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Hirschmann, Prof. Dr. med. principal investigator
Universitäres Zentrum Bewegungsapparat, Kantonsspital Baselland Bruderholz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nature sound in people with Postoperative Stress, run by Michael Tobias Hirschmann at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Basic (004161 400 60 89, daniel.basic@ksbl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressions-Angst-Stress-Skalen (DASS-21) (time frame: From the first day after surgery until the third day after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.