Sleep Assessment: The Benefits of Identifying Sleep Disturbance Using a Sleep Questionnaire

NCT ID: NCT06074224

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-12-01

Brief Summary

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The investigators are interested in measuring the influence of addressing sleep in the orthopedic setting. This includes assessing patient experience measures (satisfaction with the visit, perceived empathy, communication effectiveness) as well as greater engagement in their healthcare (patient activation). The investigators will also see what factors might be associated with sleep disturbance and if addressing sleep leads to an intervention such as cognitive behavioral therapy.

Detailed Description

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All adult (18+ years old) new patients seeing a musculoskeletal specialist will be invited to enroll. For the purposes of this trial, The investigators will include people with lesser degrees of sleep disturbance including anyone with a score greater than 3. For people that are enrolled in the trial, the researcher will record the PSQI score and enter at the first page of survey filled out by the patient after meeting. P The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit. The control group will include patients whose clinicians do not view the results, simulating usual care. Patients in both groups will fill out a survey entailing demographics, sleep quality, JSPPPE.

Conditions

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Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Clinician with Scores

The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit.

Group Type EXPERIMENTAL

Sleep assessment score

Intervention Type OTHER

The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit.

Clinician without Scores

The control group will include patients whose clinicians do not view the results, simulating usual care.

Group Type ACTIVE_COMPARATOR

No Score

Intervention Type OTHER

The patients in the control group will include those for whom their clinician was not given their sleep questionnaire result before the visit.

Interventions

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Sleep assessment score

The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit.

Intervention Type OTHER

No Score

The patients in the control group will include those for whom their clinician was not given their sleep questionnaire result before the visit.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adult patients (18+)
2. Orthopedic new visit
3. Sleep disturbance score \> 3

Exclusion Criteria

1. Inability to read.
2. Diminished cognition preventing completion of the questionnaires.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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David Ring

Professor of Surgery and Perioperative Care Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Ring, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of orthopedic surgery at The university of Texas at Austin

Locations

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University of Texas Health Austin (UTHA)

Austin, Texas, United States

Site Status

University of Texas Health Austin

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2020-05-0067

Identifier Type: -

Identifier Source: org_study_id

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