Enhancing Patient Experience of Pain and Sleep Through Non-Pharmacological Strategies

NCT04428164 | Enrolling By Invitation

• 1 other identifier: 075.NUR.2019.A
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Comfort can be a physical sensation, a psychological state, or both simultaneously . Patient comfort in an inpatient setting is a subjective state that varies from each individual based on different factors and situations. The Richards-Campbell Sleep Questionnaire (R-CSQ) and the Revised American Pain Society Outcome Questionnaire (APS-POQ-R) are tools that have been developed to assess patient satisfaction and comfort in the hospital setting. The R-CSQ is a scale used to measure different aspects of sleep quality. This scale allows the patient to rate their quality and amount of sleep on a scale of 0-100. The R-CSQ allows the patient to rate six different components of their sleep, including sleep depth, sleep latency, awakenings, returning to sleep, sleep quality, and noise. The APS-POQ-R can be utilized to measure perceived levels of pain in patients. The APS-POQ-R scale is a validated scale that is used in the hospital setting with reliable and consistent results. This scale measures five aspects of a patient's perception and experiences with pain and a sixth aspect including nonpharmacological interventions. We propose that if patients implement interventions that promote sleep and decrease pain, comfort will be improved.

Conditions

Comfort

Outcome Measures

Primary Outcomes (1)

• Patient Perception of Pain

  The Revised American Pain Society Patient Outcome Questionnaire will measure patient perception of pain. This scale measures five aspects of patient's perception and experiences with pain and a sixth aspect including nonpharmacological interventions. The scale goes from (0) - No pain to (10) - Worst Pain Possible

  From January 2021 until December 2021

Secondary Outcomes (1)

• Sleep Quality

  From January 2021 until December 2021

Study Arms (1)

Hospitalized patients

Any patient admitted to the study units (MDMC: 10ST; MCMC: A6; MMMC: A3; MRMC: 3Medical ) that do not have any of the exclusion criteria

Other: The Richards-Campbell Sleep Questionnaire (R-CSQ); Other: Revised American Pain Society Outcome Questionnaire (APS-POQ-R)

Interventions

The Richards-Campbell Sleep Questionnaire (R-CSQ) OTHER

Tool developed to assess patient satisfaction and comfort in the hospital setting. The R-CSQ is a scale used to measure different aspects of sleep quality. This scale allows the patient to rate their quality and amount of sleep on a scale of 0-100. The R-CSQ allows the patient to rate six different components of their sleep, including sleep depth, sleep latency, awakenings, returning to sleep, sleep quality, and noise.

Hospitalized patients

Revised American Pain Society Outcome Questionnaire (APS-POQ-R) OTHER

The APS-POQ-R can be utilized to measure perceived levels of pain in patients. The APS-POQ-R scale is a validated scale that is used in the hospital setting with reliable and consistent results. This scale measures five aspects of a patient's perception and experiences with pain and a sixth aspect including nonpharmacological interventions.

Hospitalized patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

60 to 80 medical surgical patients per campus (MCMC, MDMC, MMMC, MRMC) will be recruited to participate (total: 240 to 320 patients) Only adult medical surgical patients over the age 20 will be recruited.

You may qualify if:

• Hospitals eligible to participate will meet the following criteria:
• Part of the MHS (MCMC, MDMC, MMMC, MRMC)
• The hospital has at least one clinical site/sub-investigator on-staff
• Hospital has 150 or more inpatient beds
• Patients eligible to participate will meet the following criteria:

You may not qualify if:

• Age: 20+ y/o
• Must be able to speak/read/write/understand English
• Willing to utilize study interventions and complete survey booklet
• Hospitals outside of MHS will be excluded.
• Patients will be excluded for the following reasons:
• Patients admitted for surgical procedure
• Change in clinical status and deterioration requiring higher level care
• Altered mental status
• Any history of dementia and/or Alzheimer's
• Disoriented/confused
• Patients suffering with chronic pain
• Patients on patient-controlled analgesia
• Observation status patients

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Health System

Dallas, Texas, 75203, United States

Location

Study Officials

• Laura Sweatt, MSN, RN

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: February 15, 2022
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)