Effect of Music and Lighting on Anxiety During Urodynamic Study (CALM-UDS)
Effect of Environmental Factors on Patient Anxiety During Urodynamic Study: A Prospective Randomized Trial
調査の概要
詳細な説明
Urodynamic study (UDS) is an important diagnostic procedure for evaluating lower urinary tract dysfunction. Because UDS requires urethral and rectal catheterization, many patients experience anxiety before and during the procedure. This study is designed to evaluate whether environmental modifications, including relaxing music and dim lighting, reduce anxiety during UDS.
Approximately 220 adult participants are planned to be enrolled and randomly assigned in a 1:1:1:1 ratio to one of four groups: standard lighting without music, standard lighting with music, dim lighting without music, and dim lighting with music. Anxiety will be assessed before and after the procedure using the State-Trait Anxiety Inventory (STAI). Secondary outcome measures will include heart rate and blood pressure changes. The study will evaluate the independent and combined effects of music and lighting using a 2 × 2 factorial design.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mehmet Eflatun Deniz, MD
- 電話番号：+905304079085
- メール：eflatun7@gmail.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 years or older.
- Scheduled to undergo urodynamic study (UDS) for clinical indications.
- Persistent lower urinary tract symptoms despite previous medical treatment or surgery.
- Able to understand the study procedures and complete the State-Trait Anxiety Inventory (STAI).
- Provided written informed consent.
Exclusion Criteria:
- Use of anxiolytic medications.
- Use of antiarrhythmic medications.
- Use of antihypertensive medications.
- Visual or hearing impairment that could interfere with the environmental interventions or completion of the questionnaire.
- Refusal or inability to complete the STAI questionnaire.
- Inability or unwillingness to provide informed consent.
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：支持療法
- 割り当て：ランダム化
- 介入モデル：階乗代入
- 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：Standard Lighting Without Music
Participants undergo urodynamic study under standard lighting without music.
|
Standard lighting (500 lux) during the urodynamic study.
|
|
実験的：Standard Lighting With Music
Participants undergo urodynamic study under standard lighting while listening to relaxing instrumental music.
|
Standard lighting (500 lux) during the urodynamic study.
Relaxing instrumental Zen-style music played during the urodynamic study.
|
|
実験的：Dim Lighting Without Music
Participants undergo urodynamic study under dim lighting without music.
|
Ambient lighting is reduced to approximately 50 lux throughout the urodynamic study to provide a dimly lit examination environment.
|
|
実験的：Dim Lighting With Music
Participants undergo urodynamic study under dim lighting while listening to relaxing instrumental music.
|
Relaxing instrumental Zen-style music played during the urodynamic study.
Ambient lighting is reduced to approximately 50 lux throughout the urodynamic study to provide a dimly lit examination environment.
|
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 |
|---|---|---|
|
Change in State-Trait Anxiety Inventory (STAI) Score
時間枠：Immediately before and immediately after the urodynamic study
|
The primary outcome is the change in State-Trait Anxiety Inventory (STAI) score from before to after the urodynamic study.
The STAI is a validated questionnaire used to assess anxiety, with higher scores indicating greater anxiety.
The change in score will be compared between the four intervention groups.
|
Immediately before and immediately after the urodynamic study
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- KA25/238
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?
IPD プランの説明
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。