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The goal of this clinical trial is to investigate the effects of providing information to prepare for ICU stay in patients after heart surgery on anxiety and cooperative behaviors. The main questions it aims to answer are:
The researcher will provide the prepared information for ICU stay through 12-minutes VDO, 2 times before the surgery to the experimental group in addition to the usual pre-operative information (usual care). Participants in the comparison group will receive usual pre-operative information only to see if the anxiety and cooperative behaviors during a recovery period in the ICU differ between the groups.
• Participant invitation The study invitation for the prospective participants who are patients scheduled for heart surgery is posted at the cardiothoracic surgery outpatient clinic. Before deciding, patients who are interested in participating can get in touch with the researchers to learn more about the study.
Additionally, the invitation will also be posted at the in-patient facilities where patients are being admitted for heart surgery so the nurses to ask patients for their interest in being the study volunteers. The researchers will be notified if there are potential participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preparatory information | Experimental | In the experimental group, the participants will rate their anxiety before receiving the 12-minute preparation information video in addition to the usual preparation information on the day they gave consent to participate in the study. The participants will rate their anxiety again 30 minutes after the intervention. The experimental group will receive the preparation video again the second time on the day before surgery. Anxiety and treatment adherence will be measured in the ICU, 48 hours after the surgery. |
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| Usual information | Active Comparator | In the comparison group, the participants will rate their anxiety before receiving the usual preoperative information on the day they gave consent to participate in the study. The participants will rate their anxiety again 30 minutes after the usual information. Anxiety and treatment adherence will be measured in the ICU, 48 hours after the surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preparatory information for ICU stay | Behavioral | Preparatory information for ICU stay after cardiac surgery via 12-minute digital media |
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| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | The 1-Item Anxiety Visual Analogue Scale (AVAS) horizontal version is used to assess participants' level of perceived anxiety. AVAS is a numerical scale that is rated on a 10-centimeter linear scale, with 0 indicating no anxiety on the left end and 10 reflecting the most intense anxiety, representing a score of 100 on the right end. | Anxiety will be measured 3 times in both groups immediately before receiving preparatory information or usual information, 30 minutes after receiving preparatory information or usual information, and 48 hours after the surgery. |
| Treatment adherence | Treatment adherence is measured using the observational checklist developed by the researchers based on the content instructed in the preparatory information VDO. The checklist consists of 19 items in 4 categories including procedural adherence, sensory adherence, behavioral adherence, and coping adherence The checklist was evaluated by 5 experts and yielded a scale content validity index (S-CVI) of 1.0. The score of each item is rated as 0-2 scale where 0 means no adherence, 1 is partial adherence, and 2 is absolute adherence. The total possible score ranges from 0-57. | The research assistants who are blinded for the participant groups evaluate the treatment adherence 1 time at 48 hours after the surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miss KEATTIWAN KANSAARD, 1 | Contact | 66930537055 | keattiwan.k@kkumail.com | |
| Associate Prof.Dr. WASANA RUAISUNGNOEN, 2 | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Dr.RACHATA MALA, 3 | Faculty of medicine, KKU | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Srinagarind Hospital, Khon Kean University | Recruiting | Khon Kaen | 40002 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32130137 | Result | Aardoom JJ, Loheide-Niesmann L, Ossebaard HC, Riper H. Effectiveness of eHealth Interventions in Improving Treatment Adherence for Adults With Obstructive Sleep Apnea: Meta-Analytic Review. J Med Internet Res. 2020 Feb 18;22(2):e16972. doi: 10.2196/16972. | |
| 29935747 | Result | Aust H, Eberhart L, Sturm T, Schuster M, Nestoriuc Y, Brehm F, Rusch D. A cross-sectional study on preoperative anxiety in adults. J Psychosom Res. 2018 Aug;111:133-139. doi: 10.1016/j.jpsychores.2018.05.012. Epub 2018 May 22. |
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2-arm parallel randomized controlled trial study
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The research assistants who are blinded for the participant groups evaluate the outcomes including anxiety, 30 minutes after the intervention or usual care and 48 hours after the surgery and treatment adherence 1 time, 48 hours after the surgery.
| Usual information | Behavioral | Preoperative information that is given to patients before having cardiac surgery |
|
| 24888412 | Result | Bowyer A, Jakobsson J, Ljungqvist O, Royse C. A review of the scope and measurement of postoperative quality of recovery. Anaesthesia. 2014 Nov;69(11):1266-78. doi: 10.1111/anae.12730. Epub 2014 Jun 2. |
| Result | Cardiovascular thoracic intensive care unit. (2020). Srinagarind hospital adult cardiac surgery database: 2020 update. |
| 30214223 | Result | Dale JG, Midthus E, Dale B. Using information and communication technology in the recovery after a coronary artery bypass graft surgery: patients' attitudes. J Multidiscip Healthc. 2018 Aug 30;11:417-423. doi: 10.2147/JMDH.S175195. eCollection 2018. |
| 36480022 | Result | Elgazzar SE, Qalawa SAA, Ali Hassan AM. Impact of educational programme on patient's health outcomes following open heart surgeries. Nurs Open. 2023 May;10(5):3028-3041. doi: 10.1002/nop2.1549. Epub 2022 Dec 8. |