Reducing Chronic Pain Following Cesarean Delivery
A Pilot Feasibility Study of an Intervention to Reduce Chronic Pain Following Cesarean Delivery
This pilot study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain relief skills class, to postpartum women with ongoing pain and/or pain interference following cesarean delivery. Participants will receive ER in addition to standard postpartum care and will be followed through 12 weeks postpartum.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
Palo Alto、California、アメリカ、94304
- 募集
- Stanford Medicine Children's Health - Specialty Services, Welch Road
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主任研究者：
- Pervez Sultan, MD
-
コンタクト：
- Pervez Sultan, MD
- 電話番号：(669) 800 9929
- メール：psultan@stanford.edu
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Complete informed consent.
- Age 18 years or above.
- Postpartum woman who delivered by cesarean within the Stanford Healthcare system.
- Viable birth (singleton or multiple gestation).
- All maternal demographics and complications are eligible: parity, medical conditions (e.g., pre-eclampsia, gestational diabetes), and post-surgical complications (e.g., hysterectomy, ICU admission, extended hospital stay).
- All neonatal complications are eligible (e.g., NICU admission, extended hospital stay)
- Attend the 6-week postpartum clinic visit.
- Any pain intensity (numeric rating scale [NRS] >0/10) and/or pain interference (PROMIS pain interference 8a score >8) at 6 weeks postpartum.
- English fluency, with ability to read and write.
- Ability to adhere to and complete study procedures.
- Access to a smart device if attending ER session via Zoom.
Exclusion Criteria:
- Age under 18 years.
- Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
- Unable or unwilling to provide informed consent.
- Chronic pain prior to pregnancy.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Empowered Relief
Participants will receive a single 120-minute Empowered Relief session in addition to standard postpartum care. The session includes pain education and cognitive-behavioral pain management skills, including relaxation, deep breathing, reframing, and development of a personalized plan. Participants will also receive access to a smartphone relaxation resource (Calm Tool app, or a relaxation audio file if the app cannot be downloaded). |
A single 120-minute pain relief skills class delivered by trained, certified instructors via Zoom or in person. The session includes pain education, cognitive behavioral skills including relaxation, deep breathing, and reframing, and completion of a personalized plan. Following the session, participants receive access to the Calm Tool smartphone relaxation app (or a binaural relaxation audio file if the app cannot be downloaded). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of enrolled patients that complete the Empowered Relief session
時間枠：Within 2 weeks of enrollment
|
The proportion of enrolled patients that complete the single 120-minute Empowered Relief session. |
Within 2 weeks of enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of screened patients who are eligible for the study
時間枠：During screening, at approximately 6 weeks postpartum
|
The proportion of screened patients that meet the study eligibility criteria. |
During screening, at approximately 6 weeks postpartum
|
|
Proportion of eligible patients that consent to study from those approached
時間枠：During screening and enrollment, at approximately 6 weeks postpartum
|
The proportion of eligible patients who provide informed consent and enroll in the study. |
During screening and enrollment, at approximately 6 weeks postpartum
|
|
Proportion of recruited patients who register for the Empowered Relief session
時間枠：Within 1 week of enrollment
|
The proportion of recruited patients who register for the Empowered Relief session. |
Within 1 week of enrollment
|
|
Proportion of recruited patients who attend the Empowered Relief session
時間枠：Within 2 weeks of baseline
|
The proportion of recruited patients who attend an Empowered Relief session. |
Within 2 weeks of baseline
|
|
Treatment Appraisal score
時間枠：Immediately after the Empowered Relief session, up to 2 weeks post-treatment
|
Treatment satisfaction assessed using the 7-item treatment appraisal questionnaire. Range 0-42, higher = greater satisfaction with the intervention |
Immediately after the Empowered Relief session, up to 2 weeks post-treatment
|
|
Qualitative feedback regarding the Empowered Relief intervention
時間枠：Immediately after the Empowered Relief session, up to 2 weeks post-treatment
|
Participant feedback regarding the Empowered Relief intervention, provided through optional free-text responses included in the Treatment Appraisal Questionnaire. |
Immediately after the Empowered Relief session, up to 2 weeks post-treatment
|
|
Participant Treatment Skills Use Scale score
時間枠：Weekly from completion of the Empowered Relief session through 12 weeks postpartum
|
Use of skills learned during the Empowered Relief intervention assessed using the 5-item Participant Treatment Skills Use Scale. Total scores range from 0 to 25, with higher scores indicating greater use of treatment skills. |
Weekly from completion of the Empowered Relief session through 12 weeks postpartum
|
|
Adherence to Study Procedures: completion rate of scheduled surveys
時間枠：From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
|
The percentage of scheduled study surveys completed by enrolled participants. |
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
|
|
Adherence to study procedures: completion rate of scheduled PEG assessments
時間枠：From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
|
The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants. |
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
|
|
Adherence to study procedures: proportion of participants retained through end-of-study follow-up
時間枠：From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
|
The proportion of enrolled participants who remain in the study through the end-of-study follow-up assessment. |
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 84718
- K24DA053564 (米国 NIH グラント/契約)
- R90HD118650 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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