Clinical trial NCT05621265: Efficacy of Automated Text Messaging Services
Official title: Efficacy of Automated Text Messaging Services on Sleep Health, Stress, Pain, and Function in Physical Therapy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Physical Therapy
Lead sponsor: Black Hills State University
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Adults 18 years and older seeking outpatient Physical Therapy

Exclusion Criteria:

Inability to access a smart-phone or computer

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: initial visit and 4-week follow up
measure: Sleep Hygiene Index
timeFrame: initial and 4-week follow up
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: initial and 4-week follow up
measure: Patient Specific Functional Scale
timeFrame: initial and 4-week follow up
measure: Numeric Pain rating Scale
timeFrame: Initial and 4-week follow up
Other outcomes:
Locations:
city: Spearfish
country: United States
facility: Black Hills Physical Therapy
state: South Dakota
Study officials:
affiliation: Black Hills State University
name: Ashley Pfeiffer, DPT
role: PRINCIPAL_INVESTIGATOR
References: