The Influence of Natural Sounds on the Well-being of Patients After Orthopaedic Surgery

NCT07090915 | Not Yet Recruiting

• 1 other identifier: 2025-01087
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Relaxation State Questionnaire (RSQ), to measure the Relaxation

  From the first day after the surgery to the third day after the surgery.

• NRS, to measure the Painlevel

  From the first day after the surgery to the third day after the surgery.

• NRS, to measure the sleep quality

  From the first day after the surgery to the third day after the surgery.

Study Arms (2)

control group

NO INTERVENTION

standard hospital stay

Intervention group

EXPERIMENTAL

Other: nature sound

Interventions

nature sound OTHER

Modern audio technology is used to create a 3D natural atmosphere.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• duly completed declaration of consent
• the age of the patient is at least 18 years
• only patients undergoing orthopaedic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Tobias Hirschmann: lead

Study Sites (1)

Universitäres Zentrum Bewegungsapparat, Kantonsspital Baselland Bruderholz

Basel, Bruderholz, 4101, Germany

Location

Study Officials

• Michael Hirschmann, Prof. Dr. med.

  Universitäres Zentrum Bewegungsapparat, Kantonsspital Baselland Bruderholz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Basic

CONTACT

004161 400 60 89; daniel.basic@ksbl.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 29, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)