Effects of Preparatory Information on Anxiety and Treatment Adherence in Heart Surgery Patients

Heart Surgery Clinical Trial

Official title:

The Effects of Preparatory Information Using Digital Media on Anxiety and Treatment Adherence Behavior in Patients Undergoing Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201117
• Other study ID #: HE661478
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: Khon Kaen University
• Contact: Miss KEATTIWAN KANSAARD, 1
• Phone: 66930537055
• Email: keattiwan.k[@]kkumail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

• Are the anxiety levels before and after receiving prepared information video (VDO) and usual information different among participants in the experimental group?

• Are the anxiety levels between participants who received prepared information VDO and usual information and usual information only different?

• Are the cooperative behaviors during a recovery period in the ICU between participants who received prepared information VDO and usual information and usual information only different?

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.

Description:

• 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.

• Recruitment and consent process The researcher will meet with prospective participants in in-patient units where they are being admitted for surgery to discuss the study details and evaluate the Abbreviated Mental Test for screening. Potential participants who have an AMT test score of less than 8 will be excluded and thanked for their volunteer. The consent will be signed by the patients who agree to participate. The meeting will take place between 6:00 and 8:00 p.m. after patients have completed all preoperative preparations and have had dinner.

• Research assistants Two research assistants in this study are registered nurses with more than 3 years of experience in caring for heart surgery patients. They were trained to follow the study protocol and use research instruments. The interrater reliability between the researchers and research assistants is 0.96. To avoid bias, the research assistants will evaluate the outcomes in both the experimental and comparison groups while remaining blind to group allocation.

• Sample size estimation The sample size estimation was calculated using the G*Power 3.1.9.7 program for a two-sample t-test for independent with 0.8 effect size from Cohen's d formula (Cohen, 1988) using mean anxiety from a similar study. The estimated sample size needed for this study is 21 for each group with 10% adjusted for attrition resulting in 24 participants necessary for each group to demonstrate an effect.

• Data collection Data collection starts once the participants sign the consent. The participants will be allocated to a group with computer computer-generated program. Allocation to the group cannot be concealed from the participants but will be blinded to the research assistants who evaluate the outcomes. In the experimental group, the researcher asks participants to rate their anxiety before receiving the intervention (12-minute preparation information video + usual preparation information) while in the comparison group, only usual preparation information is given. The participants rated their anxiety again 30 minutes after the intervention and the usual information was given. The experimental group will receive the preparation VDO again the day before surgery. Participants in both groups rate their anxiety 48 hours after surgery and are evaluated for treatment adherence during their ICU stay. Participants who are unable to participate until the completion of the trial for any reason will be withdrawn from the study and analysis. Individual participant identities will not be recorded or disclosed in any way. Data analysis will be used to identify groups, and all recorded information will be deleted two years after the study is completed.

• Data analysis The data analysis will be performed using the Statistical Package for the Social Sciences (SPSS) version 28 software with a confidence interval of 95% (α=0.05). Descriptive statistics, Chi-square test, ANOVA, and Mann-Whitney U test will be analyzed to evaluate demographic differences between the groups depending on the normality assumption. Repeated measures ANOVA and ANCOVA will be used to analyze differences in anxiety and treatment adherence within the groups and between the groups, respectively. However, if the normality assumption is not fulfilled, the Mann-Whitney U test and Chi-square will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Attending heart surgery as scheduled for the first time

2. Never been admitted to the intensive care unit.

3. Stable condition before surgery

4. Ability to understand communication in Thai

5. Willingness to participate in the study.

Exclusion Criteria:

1. Impaired cognitive ability: assessed by the Abbreviated Mental Test (AMT) when the score is less than 8 out of 10.

2. Admitted to the hospital in an emergency and need urgent surgery.

Related Conditions & MeSH terms

• Heart Surgery

Intervention

Behavioral:
• Preparatory information for ICU stay
Preparatory information for ICU stay after cardiac surgery via 12-minute digital media
• Usual information
Preoperative information that is given to patients before having cardiac surgery

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital, Khon Kean University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

Aardoom, J. J., Loheide-Niesmann, L., Ossebaard, H. C., & Riper, H. (2020). Effectiveness of eHealth Interventions in Improving Treatment Adherence for Adults With Obstructive Sleep Apnea: Meta-Analytic Review. Journal of Medical Internet Research, 22(2).

Aust, H., Eberhart, L., Sturm, T., Schuster, M., Nestoriuc, Y., Brehm, F., & Rüsch, D. (2018). A cross-sectional study on preoperative anxiety in adults. Journal of Psychosomatic Research, 111, 133-139. https://doi.org/10.1016/J.JPSYCHORES.2018.05.012

Bowyer, A., Jakobsson, J., Ljungqvist, O., & Royse, C. (2014). A review of the scope and measurement of postoperative quality of recovery. In Anaesthesia (Vol. 69, Issue 11, pp. 1266-1278). https://doi.org/10.1111/anae.12730

Cardiovascular thoracic intensive care unit. (2020). Srinagarind hospital adult cardiac surgery database: 2020 update.

Dale, J. G., Midthus, E., & Dale, B. (2018). Using information and communication technology in the recovery after a coronary artery bypass graft surgery: Patients' attitudes. Journal of Multidisciplinary Healthcare, 11, 417-423. https://doi.org/10.2147/JM

Elgazzar, S. E., Qalawa, S. A. A., & Ali Hassan, A. M. (2022). Impact of educational program on patient's health outcomes following open heart surgeries. Nursing Open. https://doi.org/10.1002/nop2.1549

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.