Effect of Provision of Information and Supportive Nursing Care: A Randomised Controlled Trial

NCT04834037 | Completed DMC

• 1 other identifier: B.30.2.ODM.0.20.08/390
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Informative and supportive nursing care is essential to reduce complications and improve outcomes in Chronic Obstructive Pulmonary Disease (COPD) patients treated with Non-Invasive Ventilation (NIV). Objective: Aim of the study is to determine the effect of provision of information and supportive nursing care on blood gas, vital signs, anxiety, stress and agitation levels in COPD patients treated with NIV. Research Methodology: A randomised controlled design was used between September-December 2019. The universe of the study consisted of COPD patients treated with NIV in intensive care unit in a state hospital. A total of 60 patients, composed of 30 interventions and 30 controls, were randomly included in the sample. Provision of information and supportive nursing care was applied to the patients in the intervention group. The data were evaluated with SPSS program. Results: Following the intervention, the findings showed that the provision of information and supportive nursing care has a positive effect on the blood gas, vital signs, anxiety, stress and agitation levels of patients. Conclusions: The provision of information and supportive nursing care is recommended to alleviate anxiety, stress and agitation in COPD patients treated with NIV

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Anxiety, Agitation, Noninvasive Ventilation, Intensive care

Outcome Measures

Primary Outcomes (3)

• Depression Anxiety Stress Scale (DASS-21)

  The scale was first developed by Lovibond and Lovibond (1995) with 42 items and three sub-dimensions. It was later revised to 21 items by Brown et al. (1997) in 1997. The scale is 4-point Likert type, consists of 21 items and 3 sub-dimensions (depression, anxiety, stress). The adaptation of the scale to Turkish and its validity and reliability studies were conducted by Yılmaz et al. (2017). Evaluation is obtained by summing the scores given to the items it contains for each sub-dimension. Minimum 0 and maximum 21 points can be obtained in all dimensions. The subscales of the scale are Cronbach's alpha values; depression 0.81, anxiety 0.80, stress 0.75 (Yılmaz et al., 2017).

  3 months

• Richmond Agitation-Sedation Scale (RASS)

  RASS scale was developed by a multidisciplinary team at Virginia Common Wealth University (Sessler et al. , 2002). RASS is a 10-point scale that is evaluated using verbal stimulation followed by eye contact, which is not available in other scales. It is proven that RASS has excellent validation compared to a wide range of visual analog scales and selected sedation measurements for adult medical and surgical intensive care patients. While zero (0) points on the scale indicate the ideal level, it reflects the increasing agitation towards the (+4) level and the decreasing sedation level to the (-5) level. Since patients receiving sedation were not included in this study, only the agitation dimension of the RASS scale was used.

  3 months

• Glaskow Coma Scale (GCS)

  It was developed in Scotland / Glasgow in 1974 to describe the consciousness level of patients. The scale is widely used to assess patients' level of consciousness. There are 3 separate sections in the scale: eye opening, verbal and motor response. GCS is obtained by summing the points the patient gets from each section. This score ranges from three (3) to fifteen (15). If the GCS total score is 13-15, the patient is considered awake, between 8-12 as precoma, and below 8 as coma (Sepit, 2005).

  3 months

Study Arms (2)

Experimental

EXPERIMENTAL

Patients in the experimental group were provided with information in addition to routine nursing care and supportive care interventions were made. The information leaflet was explained to the patients in the experimental group face to face by the researchers and the information was repeated according to the patient's needs. As a pre-test measure, blood gases were taken from the patients in the experimental and control groups, their vital signs were measured, their state of consciousness was evaluated, and DASS-21 (anxiety and stress sub-dimension) and RASS (agitation dimension) were practiced by face-to-face interviews with the patients. As the last test, the same measurements were made 5 days after the first measurement and before the patients were transferred to the normal service. An information pamphlet consisting of textual material about NIV treatment was developed.

Behavioral: Behavioral

No intervention

NO INTERVENTION

Routine nursing care was practiced to the control group in the intensive care clinic where the patients were located.

Interventions

Behavioral BEHAVIORAL

The provision of information and supportive nursing care is recommended to alleviate anxiety, stress and agitation in COPD patients treated with NIV.

Experimental

Eligibility Criteria

• Age: 48 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of COPD treated with NIV be conscious of agreement to participate in the study COPD patients starting NIV therapy for the first time

You may not qualify if:

• intubated therefore unable to speak received sedation had a Glaskow Coma Scale score below 14 were excluded

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Bafra State Hospital

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Anxiety Disorders; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• İlknur AYDIN AVCİ, Prof.

  Ondokuz Mayıs University

  STUDY DIRECTOR

• Yasemin ÇEKİÇ, Dr.

  Ankara University

  PRINCIPAL INVESTIGATOR

• Tuba YILMAZ BULUT, Msc

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nursing Department

Model Details: Randomized controlled experimental design

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 6, 2021
• Study Start: September 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2020
• Last Updated: June 2, 2021

Record last verified: 2021-06

Locations

TU (1)