The Effect of Multisensory Stimulation Administered Before Clinical Encounters at the Pediatric Surgery Outpatient Clinic on Children's Anxiety and Fear Levels and Parental Anxiety
The Effect of Multisensory Stimulation Administered Before Clinical Encounters at the Pediatric Surgery Outpatient Clinic on Children's Anxiety and Fear Levels and Parental Anxiety: A Randomized Controlled Study
調査の概要
詳細な説明
In recent years, there has been an interest in non-pharmacological interventions to address anxiety and fear levels in pediatric healthcare. Methods such as distraction techniques, digital applications, game solutions, and multisensory stimulation have proven effective in children's health experiences. Multisensory stimulation, particularly with materials containing content targeting the senses of sight, hearing, smell, and touch, is a holistic, non-pharmacological approach that helps reduce developmental stage problems, behavioral issues, pain, fear, and anxiety in children. In its basic mechanism, multisensory stimulation activates tactile, thermal, and emotional systems, providing multiple stimuli and diverting children's attention away from the stressor through simultaneous auditory stimuli. The resulting sensory integration and attention redirection effect can contribute to the improvement of anxiety and fear levels. Among multisensory stimulation applications are: Mother-baby communication, skin-to-skin contact, breastfeeding which activates sensory receptors and taste in the skin, the use of amniotic fluid or aromatic scents are included. In addition, practices such as making eye contact with the baby, speaking in a soft tone of voice, massaging, coordinating and using parental credit are among the components of multisensory stimulation. However, it is noted that this is largely focused on childbirth and that the clinical limits are restricted.
There is limited scientific evidence in the literature that multisensory stimulation may be effective in reducing pain and fear, especially after surgical procedures, in the days of birth. It is observed that the current centers, with multiple voice alerts, are quite limited in addressing the anxiety and fear at home before clinical encounters in pediatric surgery outpatient clinics, where most neonatal or pre-operative processes are evaluated, and the situational anxiety of individuals is addressed together with outbreaks. However, the outpatient setting has critical relationships as the first point of contact with the modern health system, and the anxiety, fear, and parental anxiety experienced at this stage significantly affect the child's subsequent health experiences and compliance with health services. Therefore, the emergence of effective, short-term, and non-pharmacological interventions in the pre-clinical encounter period will be of great importance. In line with this, these randomized controlled trials are planned to examine the effect of multiple sensory stimuli on the situational anxiety of individuals in pediatric surgery outpatient clinics, prior to clinical encounters, and in terms of anxiety and fear. The study results will contribute to supporting a low-level, effective, and effective intervention in pediatric surgery outpatient clinics. Furthermore, it will lay the groundwork for demonstrable practices that will strengthen this developmental, child and family-centered care approach and contribute to the widespread use of psychosocial support practices in pediatric health services.
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:Fulya Merve FMK KOS, Assis Prof Dr
- 電話番号:05300974816
- メール:fulya.kos@bilecik.edu.tr
研究場所
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Turkey
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Bilecik、Turkey、トルコ(Türkiye)、11230
- Bilecik Seyh Edebali University
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コンタクト:
- Fulya KOS
- 電話番号:05300974816
- メール:fulya.kos@bilecik.edu.tr
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- For the children to be sampled, the inclusion criteria plan to involve children who:
- Are aged between 5 and 10 years,
- Are undergoing their first outpatient pediatric surgery evaluation,
- Have no prior history of surgery, and Agree (along with their parents) to voluntarily participate in the study.
Exclusion Criteria:
- For the children to be sampled, the exclusion criteria plan to omit children who:
- Are in unstable general condition or require emergency medical intervention,
- Have intellectual disabilities, or Have visual or hearing impairments.
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:ヘルスサービス研究
- 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 |
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実験的:The Effect of Multisensory Stimulation on Pain and Anxiety in Children with Pediatric Surgery
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多感覚刺激
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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 |
|---|---|---|
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Children's Pre-procedural Anxiety Level
時間枠:(Baseline / Pre-encounter
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Children's Anxiety Scale - State Scale The CAS-S resembles a thermometer featuring a bulb at the bottom and horizontal lines spaced at intervals as they rise upwards.
Designed for children aged four to ten, this scale instructs children to "Imagine that all your anxious or nervous feelings are in the bulb or lower part of the thermometer."
"If you feel a little anxious or tense, your feelings may rise a little higher on the thermometer.
"Put a line on the thermometer to show how anxious or nervous you are."
It was discovered during the researchers' data collection process that some children were familiar with the typical mercury thermometer represented on the scale, and when children did not understand this analogy, they used an alternative scenario that did not explicitly describe a thermometer.
Children are told, "Think of all the anxious or nervous feelings as being at the bottom here (point with your finger on the scale).
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(Baseline / Pre-encounter
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Children's Fear Level
時間枠:Baseline / Pre-encounter
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The Child Fear Scale (CFS), validated and proven reliable by Gerçeker et al. (2018), is used to measure a child's anxiety level.
The CFS is a scale that evaluates children's anxiety levels using a 0-4 rating system, consisting of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety).
It can be used by families and researchers to assess pre-procedural and intra-procedural pain and anxiety in children and is aimed at children aged 5-10 years.
The CFS is based on the Faces Anxiety Scale developed by McKinley et al. (2003) to measure the fear or anxiety of adults in the intensive care unit.
It is a scale consisting of one item and five gender-neutral faces.
The facial muscle changes in the fearful expressions were drawn by a graphic artist based on photographs of frightened faces.
The scale will be administered to children as a pre-test and post-test.
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Baseline / Pre-encounter
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Parental State Anxiety Level
時間枠:Baseline / Pre-encounter
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State-Trait Anxiety Inventory A 10-item short version of the 40-item State-Trait Anxiety Inventory (STAI) was developed by Zsido et al. In the process of shortening the STAI, Zsido et al. (2020) first removed the reverse-scored items from the scale and then reduced these inventories to their short 5-item forms (STAIS-5 and STAIT-5) by performing confirmatory factor analysis (CFA), item response theory analysis, and ROC analysis to preserve the best discriminating items. The 4-point Likert-type scales consist of 5 items. The emotions and behaviors indicated in STAIS-5 are marked according to their degree of severity as 1 = None, 2 = Somewhat, 3 = Moderately, 4 = Very much; and the STAIT-5 items are marked as 1 = None, 2 = Sometimes, 3 = Moderately, 4 = Very much. Individuals scoring 10 or higher on STAIS-5 and 14 or higher on STAIT-5 are considered clinically anxious. The Cronbach's alpha values for STAIS-5 and STAIT-5 were calculated as 0.86 and 0.91. |
Baseline / Pre-encounter
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協力者と研究者
出版物と役立つリンク
一般刊行物
- No publications resulting from this study are available at this time as the trial is currently ongoing.
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
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
Individual Participant Data (IPD) will not be made publicly available or shared for this study due to ethical considerations regarding participant confidentiality and the explicit terms of the informed consent protocol.
Specifically:
Informed Consent Constraints: The informed consent forms approved by the Institutional Review Board (IRB) / Ethics Committee and signed by the parents/guardians do not include permissions for raw, individual-level data sharing with external third parties or public repositories.
Privacy and Vulnerability: Given that the study population consists of pediatric patients undergoing clinical evaluations, raw IPD contains sensitive demographic and clinical details that could potentially compromise participant anonymity.
De-identified aggregate statistical data, protocol details, and final study findings will be made available through published peer-reviewed journal articles and clinical trial registries upon study completion.
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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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