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

NCT06201117 | Unknown DMC

• 1 other identifier: HE661478
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Surgery

Keywords

Heart Surgery, Digital Media, Preparatory Information

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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.

Behavioral: Preparatory information for ICU stay; Behavioral: Usual information

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.

Behavioral: Usual information

Interventions

Preparatory information for ICU stay BEHAVIORAL

Preparatory information for ICU stay after cardiac surgery via 12-minute digital media

Preparatory information

Usual information BEHAVIORAL

Preoperative information that is given to patients before having cardiac surgery

Preparatory information; Usual information

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Attending heart surgery as scheduled for the first time
• Never been admitted to the intensive care unit.
• Stable condition before surgery
• Ability to understand communication in Thai
• Willingness to participate in the study.

You may not qualify if:

• Impaired cognitive ability: assessed by the Abbreviated Mental Test (AMT) when the score is less than 8 out of 10.
• Admitted to the hospital in an emergency and need urgent surgery.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Srinagarind Hospital, Khon Kean University

Khon Kaen, 40002, Thailand

RECRUITING

Related Publications (6)

• 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.

  PMID: 32130137 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.

  PMID: 29935747 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.

  PMID: 24888412 RESULT

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

  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.

  PMID: 30214223 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.

  PMID: 36480022 RESULT

Study Officials

• Dr.RACHATA MALA, 3

  Faculty of medicine, KKU

  STUDY CHAIR

Central Study Contacts

Miss KEATTIWAN KANSAARD, 1

CONTACT

66930537055; keattiwan.k@kkumail.com

Associate Prof.Dr. WASANA RUAISUNGNOEN, 2

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Nursing

Model Details: 2-arm parallel randomized controlled trial study

Study Record Dates

• First Submitted: December 31, 2023
• First Posted: January 11, 2024
• Study Start: December 27, 2023
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)