Efficacy of Automated Text Messaging Services

Sleep Clinical Trial

Official title:

Efficacy of Automated Text Messaging Services on Sleep Health, Stress, Pain, and Function in Physical Therapy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621265
• Other study ID #: BlackHillsSTATE
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2022
• Source: Black Hills State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test automated text messaging as an effective behavior change intervention in physical therapy patients. The main purpose of this study was to trial sleep hygiene education for improving physical therapy patients' sleep through the use of daily automated text messaging. Researchers will compare two groups to see if the intervention group which consisted of participants getting daily automated text messages for sleep hygiene tips would be effective in improving sleep, health, pain, and function compared to a group that is receiving traditional physical therapy alone.

Description:

Participants will be recruited from the outpatient physical therapy clinic verbally by their therapist and by an informational handout they receive from the therapist. The student researcher (who also works at this clinic) will then contact the participant to set up a time to complete the initial survey questions at the clinic in a private treatment room. During the initial visit, participants will read through and sign informed consent explaining the procedures and expectations of them during the study. The participants will then complete the following questionnaires: Pittsburgh Sleep Quality Index, Sleep Hygiene Index, Medical Outcome Survey-sleep 9, Perceived Stress Scale, Numeric Pain Rating Scale, and Patient Specific Functional Scale. The participants will randomly be assigned to one of two groups. The intervention group will receive daily automated text messages scheduled for 8:00 pm every evening. The text messages will include a variety of sleep hygiene behavioral tips for the participant to try. This will last for a total of four weeks. The control group will not receive any intervention during this time frame. Following the four weeks, student researchers will return to each participant's clinic to collect the same data that was collected at the initial visit. Each participant will have a total of 2 sessions to complete with each session taking approximately 15-30 minutes to complete.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adults 18 years and older seeking outpatient Physical Therapy

Exclusion Criteria:

Inability to access a smart-phone or computer

Related Conditions & MeSH terms

• Physical Therapy
• Sleep

Intervention

Behavioral:
• Automated Text messaging
daily text message

Locations

Country	Name	City	State
United States	Black Hills Physical Therapy	Spearfish	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Black Hills State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index	sleep quality measurement. Scores range 0-21 with higher score indicating poorer sleep quality.	initial visit and 4-week follow up
Primary	Sleep Hygiene Index	measuring participants sleep hygiene behaviors. Scores range 0-52 with a higher score indicating poorer sleep hygiene.	initial and 4-week follow up
Secondary	Perceived Stress Scale	stress measurement. Scores range 0-40 with higher score indicating greater stress.	initial and 4-week follow up
Secondary	Patient Specific Functional Scale	scale for improving patient's top three chosen functions they want to improve. Scores range from 0-10 with lower scores indicating poorer function.	initial and 4-week follow up
Secondary	Numeric Pain rating Scale	tool to measure pain. 0-10 with 10 being highest pain possible.	Initial and 4-week follow up