The REST feasibility trial: sleep and pain in patients undergoing total knee replacement

REST: A prospective randomised feasibility study assessing the impact of a tailored sleep intervention in patients undergoing total knee replacement (TKR)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14233189

Enrollment

Registered

2021-03-25

Start date

2021-03-25

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep quality in patients scheduled to undergo total knee replacement surgery Surgery

Interventions

REST is a two-centre feasibility RCT with embedded health economics and qualitative work. Patients on the waiting list for a total knee replacement at North Bristol NHS Trust (Bristol) or Cardiff and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. On the waiting list for a primary TKR due to osteoarthritis 2. Aged 18 years and over 3. Experiencing disturbed sleep, defined as a score of 0-28 on the Sleep conditions indicator

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 01/12/2023: 1. Diagnoses with a clinical sleep disorder, assessed via screening questionnaire (e.g. clinical insomnia) 2. Currently receiving treatment for a clinical sleep disorder, assessed via screening questionnaire 3. Taking prescription medication to help with sleep 4. Unable or unwilling to attend intervention appointment 5. Unable or unwilling to provide informed consent 6. Unable to complete study questionnaires in English _____ Previous exclusion criteria: 1. Diagnoses with a clinical sleep disorder, assessed via screening questionnaire (e.g. clinical insomnia) 2. Currently receiving treatment for a clinical sleep disorder, assessed via screening questionnaire 3. Unable or unwilling to attend intervention appointment 4. Unable or unwilling to provide informed consent 5. Unable to complete study questionnaires in English

Design outcomes

Primary

Measure	Time frame
Collected by patient completed questionnaires at baseline, one week prior to surgery and three months after surgery: 1. Knee pain and function measured using the Oxford Knee Score 2. Neuropathic components in pain measured using PainDETECT 3. Sleep quality measured using the Sleep Condition Indicator 4. Sleep quality measured using the Pittsburgh Sleep Quality Index 5. Anxiety and depression measured using the Hospital Anxiety and Depression Scale 6. Quality of life measured using the EQ-5D-5L 7. Capability measured using ICECAP-A	—

Measure

Time frame

Collected by patient completed questionnaires at baseline, one week prior to surgery and three months after surgery: 1. Knee pain and function measured using the Oxford Knee Score 2. Neuropathic components in pain measured using PainDETECT 3. Sleep quality measured using the Sleep Condition Indicator 4. Sleep quality measured using the Pittsburgh Sleep Quality Index 5. Anxiety and depression measured using the Hospital Anxiety and Depression Scale 6. Quality of life measured using the EQ-5D-5L 7. Capability measured using ICECAP-A

—

Secondary

Measure	Time frame
Additional resource use data will be collected in the pre and post-op questionnaires only, which includes primary and secondary health care interactions, medication use and patient out of pocket expenditure and productivity	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026