Promoting Sleep to Alleviate Pain - Arthroplasty
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Cognitive behavioral therapy for insomnia (CBT-I), Sleep education therapy (SET).
- Кому может быть актуально
- Состояния в реестре: Osteoarthritis, Knee, Osteoarthritis, Hip, Insomnia, Surgery. Базовые параметры: 18 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial
Обзор
PROSAP-A is a perioperative randomized, controlled trial with a 12-month follow-up period after total knee arthroplasty (TKA) or total hip arthroplasty (THA), aiming to investigate both acute and long-term postoperative effects of preoperative sleep-promotion. Participants with clinically significant insomnia symptoms will be randomized to a brief, hybrid version of cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy, administered over a 4-week period, prior to surgery. The primary objective is to evaluate effects of preoperative sleep-promotion on acute postoperative pain control. Secondary objectives include evaluation of postoperative sleep, recovery, mental health, cognitive function and alterations in blood biomarkers.
Подробное описание
Although preoperative sleep disturbance is associated with poorer acute postoperative pain control, as well as development of chronic postsurgical pain, only very limited attempts have been made to target preoperative sleep to achieve improved postoperative outcomes. This study addresses two chronic pain populations, TKA and THA patients, that suffer severely due to both sleep disturbance and painful symptoms. Patients who meet eligibility criteria, including insomnia severity index score \>10 and confirmed DSM-V criteria for persistent insomnia disorder, will be randomized to a brief, hybrid version of CBT-I or sleep education therapy over a 4-week period, before surgery. The CBT-I will focus on the two components which have shown the highest efficacy for sleep improvement, sleep restriction therapy and stimulus control. The CBT-I treatment will be administered in self-guided digital format with addition of telehealth video-consultations with a psychologist one time per week. The sleep education therapy will also be provided in a hybrid format, including digital sessions and video-consultations with a research nurse. There will also be a booster session 1-2 weeks postoperative for both interventions. Participants will be carefully evaluated during on-site visits two times preoperative, pre- and post-intervention, and one time 6 months postoperative. During on-site visits, participants will complete multiple questionnaires (covering pain, pain catastrophizing, mental health, physical function, activity etc), undergo digital cognitive testing, quantitative sensory testing (QST, to determine pain detection thresholds to different stimuli, assess temporal summation, pain inhibitory capacity), provide blood samples, and initiate actigraphy (objective assessment of sleep continuity measures). In addition to the on-site visits, participants will complete questionnaires remotely 3 and 12 months after surgery.
Вмешательства
- Поведенческое Cognitive behavioral therapy for insomnia (CBT-I)
Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist) - Поведенческое Sleep education therapy (SET)
Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse
Первичные конечные точки
- Acute postoperative pain intensity [Срок оценки: First 7 postoperative days]
Вторичные конечные точки (12)
- Pre- and acute postoperative change in sleep measures from baseline [Срок оценки: Up to 2 weeks postoperative]
- Acute postoperative opioid consumption [Срок оценки: Postoperative day (POD) 1 and POD1-7]
- Recovery in the acute postoperative phase [Срок оценки: First 7 postoperative days]
- Long-term postoperative sleep quality [Срок оценки: Up to 12 months postoperative]
- Postoperative objective sleep continuity [Срок оценки: Up to 6 months postoperative]
- Pain intensity 6 months postoperative [Срок оценки: 6 months postoperative]
- Change in pain measures from baseline [Срок оценки: Up to 12 months postoperative]
- Changes in quantitative sensory testing (QST) measures of pain [Срок оценки: Up to 6 months postoperative]
- Change in cognitive function [Срок оценки: Up to 6 months postoperative]
- Change in anxiety from baseline [Срок оценки: Up to 6 months postoperative]
- Change in depression from baseline [Срок оценки: Up to 6 months postoperative]
- Change in quality of life [Срок оценки: Up to 6 months postoperative]
Критерии участия
Критерии включения
- age ≥18 years
- insomnia severity index score >10
- fulfill DSM-V criteria for persistent insomnia disorder
- average pain numerical rating scale (NRS) score ≥4 (scale 0 - 10) and/or movement-related pain NRS score ≥4 after 5 minutes walking
- scheduled to undergo primary (first-time, i.e., not revision surgery) TKA or THA due to osteoarthritis
Критерии исключения
- uncontrolled medical disorders
- nightshift work
- ongoing major depressive disorder, bipolar disorder, psychotic disorder, substance dependence
- current history or high likelihood of primary sleep disorders (other than insomnia), including obstructive sleep apnea syndrome, narcolepsy, nocturnal myoclonus
- severely impaired vision (precluding ability to take part of study interventions)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
Швеция · 1 центр
- Department of Surgical Sciences, Uppsala University — Uppsala
Публикации
- Bjurstrom MF, Bothelius K, Maathz P, Jernelov S, Kraepelien M, Rosenstrom AHC, Niklasson A, Smith MT, Olmstead R, Irwin MR, Finan PH, Kosek E. Randomised, controlled clinical trial evaluating the effects of preoperative insomnia treatment on postoperative pain control and recovery: a protocol for the Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) trial. BMJ Open. 2025 Jul 30;15(7):e0997 PMID 40738630
Идентификаторы
NCT: NCT06145516 · Dnr 2023-03976-01