NCT06848777

Brief Summary

The Effect of Mobilization Using Nature Sounds on Patients' Anxiety, Pain and Stress Levels

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 22, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 2, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

February 22, 2025

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Anxiety

    Anxiety level will be measured withVirtual Analog Scale-Anxiety (The lowest score is set as 0, and the highest score is set as 10.)

    Before mobilization 5 minutes and after mobilization 10 minutes

  • Stress

    with smart watch

    before mobilization 5 minutes and after mobilization 10 minutes

  • Pain level

    Pain level will be measured with Virtual Analog Scale (The lowest score is set as 0, and the highest score is set as 10.)

    before mobilization 5 minutes and after mobilization 10 minutes

Study Arms (2)

Control Group

NO INTERVENTION

The standard care protocol of the service will be applied to the patients in the control group. The patients will be mobilized.(

Intervention Group

EXPERIMENTAL

Patients in this group will be mobilized and will be played nature-based sounds through headphones.

Behavioral: Intervention group:

Interventions

After a 50-meter walk while listening to the sounds of nature, the patient will walk 50 meters again to his/her room and then to his/her bed, where he/she will be seated. Then, the researcher nurse will remove the headphones from the patient's ears and ensure that the patient rests in a comfortable position.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Individuals who are willing to participate in the study,
  • Patients undergoing their first laparoscopic surgery due to gallbladder stones,
  • Patients scheduled for elective surgical procedures,
  • Patients with no hearing impairment,
  • Patients with no vision impairment,
  • Mentally stable individuals,
  • Individuals who are open to communication and cooperation,
  • Patients aged 18 years and older will be included in the study.

You may not qualify if:

  • Individuals with mental health issues,
  • Individuals who are unwilling to participate,
  • Patients with hearing impairment,
  • Patients undergoing their second surgery (recurrent) due to gallbladder stones,
  • Patients using hearing aids,
  • Individuals who are uncooperative or unwilling to communicate,
  • Patients who require emergency surgery will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kumluca State Hospital

Antalya, Kumluca, 07350, Turkey (Türkiye)

Location

Trakya University

Edirne, Merkez, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
To ensure that the recording of the data process was unbiased in this study, patients' anxiety and pain levels were assessed by asking patients questions and having them mark their responses on paper under the supervision of the nurse researcher, while the obtained anxiety and pain scores and the stress levels measured using a smartwatch were recorded on the forms by the independent ward nurse. The results of the study findings were analyzed by an independent statistician.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Dr.

Study Record Dates

First Submitted

February 22, 2025

First Posted

February 27, 2025

Study Start

March 2, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 7, 2026

Record last verified: 2026-04

Locations