Nature Image Exposure in Type 2 Diabetes
Effects of Nature Image Exposure on Pain, Fear of Blood Glucose Testing and Fear of Self-injection in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Type 2 diabetes often requires repeated procedures, including insulin self-injection and self-monitoring of blood glucose. These procedures may cause pain and lead to fear of self-injection and blood glucose testing, which may negatively affect treatment adherence and diabetes self-management. Nature-based visual stimuli may serve as a simple, non-pharmacological distraction method by directing attention away from painful or fear-inducing procedures.
This randomized controlled trial evaluated the effects of nature image exposure on pain, fear of self-injection, and fear of blood glucose testing in adults with type 2 diabetes. A total of 64 participants were randomly assigned to either the intervention group (n=32) or the control group (n=32). Participants in the intervention group viewed a standardized nature image displayed on a fixed wall-mounted screen for 3-5 minutes immediately before insulin self-injection and self-monitoring of blood glucose. Participants in the control group received standard care without nature image exposure. Outcomes were assessed using the Diabetes Fear of Injecting and Self-Testing Questionnaire and the Visual Analog Scale.
調査の概要
詳細な説明
Study design This was a randomized controlled trial with blinded participants and blinded statistical analysis.
Setting and time The study was conducted between November 2023 and November 2024 in the Endocrinology Service Dicle University. The service consists of 8 rooms and 22 beds and is staffed by 5 faculty members, 4 residents, 1 diabetes education nurse, 9 clinical nurses, and 2 podologists. The diabetes education nurse provides individual education to all newly admitted patients with diabetes. This education includes insulin injection technique and rotation, insulin storage conditions, self-monitoring and follow-up, medical nutrition therapy, and exercise management. Education is also provided to patients' relatives.
Population and sample The study population consisted of 64 patients with type 2 diabetes who were followed in the Endocrinology Service of ---University -- between November 2023 and November 2024 and met the inclusion criteria. Inclusion criteria were: having been diagnosed with diabetes for at least one year, current use of insulin, ability to understand and speak Turkish, no prior exposure to nature image exposure interventions, performing insulin injections at least twice daily, and conducting blood glucose monitoring at least twice daily. Exclusion criteria included having a psychiatric diagnosis, refusal to participate, vertigo, visual or hearing impairment, and cognitive disability. Based on these criteria, eligible participants were identified, and a total of 64 patients were included in the study.
Sample size and power analysis Sample size estimation was performed a priori using G*Power version 3.1 [21] based on the fear of self-injection scale scores reported in the study by Aktura and Sarıtaş. [22] Assuming a large effect size (Cohen's d = 0.80), a statistical power of 80%, and a significance level of 5% (α = 0.05), the minimum required sample size was calculated as 42 participants, with at least 21 participants in each group. To compensate for potential participant loss and to increase the statistical robustness of the study, the sample size was expanded, and 32 participants were included in each group.
Blinding This was a randomized controlled trial in which participants were blinded to group allocation, and statistical analyses were performed by an independent statistician who was blinded to group assignments. However, outcome assessment and data collection were performed by the researcher, who was aware of group allocation; therefore, outcome assessors were not blinded.
Data collection instruments Data were collected using a Participant Information Form, the Diabetes Fear of Self-Injecting and Self-Testing Questionnaire (D-FISQ), and the Visual Analog Scale (VAS).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Di̇yarbakir
-
Diyarbakır、Di̇yarbakir、トルコ（Türkiye）、21280
- Dicle University Hospitals
-
-
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
Diagnosis of type 2 diabetes mellitus for at least one year Current use of insulin Ability to understand and speak Turkish No previous exposure to a nature image exposure intervention Performing insulin self-injection at least twice daily Performing self-monitoring of blood glucose at least twice daily Willingness to participate and provision of written informed consent
Exclusion Criteria:
Poor mental health Having gestational diabetes mellitus or Type 1 Diabetes Vertigo Visual impairment Hearing impairment
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：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Nature Image Exposure Group
On Day 1, participants underwent routine self-monitoring of blood glucose and insulin injection without any intervention, and baseline measurements were obtained. On Day 2, participants viewed a standardized, high-resolution nature-themed visual displayed on a fixed wall-mounted screen for 3-5 minutes immediately before self-monitoring of blood glucose and insulin injection. Post-intervention measurements were then obtained using the same instruments. |
Participants were individually exposed to a standardized, high-resolution nature-themed visual depicting natural environments such as forests, rivers, waterfalls, and green landscapes. The visual was displayed on a fixed wall-mounted screen in the diabetes education room for 3-5 minutes immediately before self-monitoring of blood glucose and insulin injection. Environmental conditions were standardized, including uniform room lighting, minimal noise, a fixed seating position, and a consistent viewing distance. The visual display was removed immediately after each session. |
|
介入なし：Standard Care Control Group
Participants received standard care without nature image exposure. On Day 1, baseline measurements were obtained following routine self-monitoring of blood glucose and insulin injection. On Day 2, participants continued routine self-monitoring of blood glucose and insulin injection without any visual intervention, after which post-test measurements were obtained using the same instruments. |
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 Pain Intensity Assessed Using the Visual Analog Scale (VAS)
時間枠：Baseline on Day 1 and post-intervention on Day 2, over two consecutive days
|
Pain intensity associated with self-monitoring of blood glucose and insulin injection was assessed using the Visual Analog Scale (VAS). The VAS consists of a 10-cm (100-mm) horizontal line anchored by "no pain" at one end and "worst imaginable pain" at the other end. Participants marked the point that best represented their current pain intensity. Scores range from 0 to 10, with higher scores indicating greater pain intensity. Baseline pain was assessed on Day 1 following routine self-monitoring of blood glucose and insulin injection without any intervention. Post-intervention pain was assessed on Day 2 following nature image exposure and the procedures in the intervention group or following the same procedures under standard care in the control group. |
Baseline on Day 1 and post-intervention on Day 2, over two consecutive days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Fear of Self-Injection and Self-Testing Assessed Using the D-FISQ
時間枠：Baseline on Day 1 and post-intervention on Day 2, over two consecutive days
|
Fear of self-injection and fear of blood glucose testing were assessed using the Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ). The questionnaire consists of 15 items and includes two subscales: fear of self-injecting (6 items) and fear of self-testing (9 items). Each item is rated on a four-point Likert scale ranging from 0 ("almost never") to 3 ("almost always"). The fear of self-injecting subscale score ranges from 0 to 18, the fear of self-testing subscale score ranges from 0 to 27, and the total D-FISQ score ranges from 0 to 45. Higher scores indicate greater fear. Baseline measurements were obtained on Day 1 following routine self-monitoring of blood glucose and insulin injection without any intervention. Post-intervention measurements were obtained on Day 2 following nature image exposure in the intervention group or standard care in the control group. |
Baseline on Day 1 and post-intervention on Day 2, over two consecutive days
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
キーワード
その他の研究ID番号
- DICLE-ARDASURUCU-001
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
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。