Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04834037 |
| Other study ID # |
B.30.2.ODM.0.20.08/390 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2019 |
| Est. completion date |
December 30, 2020 |
Study information
| Verified date |
June 2021 |
| Source |
Ondokuz Mayis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
Trial design and the participants A randomised controlled design was used between
September-December 2019. This study has been approved (B.30.2.ODM.0.20.08/390) by an ethics
committee. In order to carry out the study, an application permit (17186359-604.02) was
obtained from the Provincial Health Directorate and the relevant hospital. In addition,
written consent forms were obtained from all the patients.
The sample size was determined using G * Power 3.1 software since there was no pilot data.
According to the power analysis, the number of the participants was calculated as at least 54
when a type 1 error was taken as 0.05, power as 0.95, and the effect size as moderate (0.25)
for two groups design with two repeated measures. In order to prevent possible data loss, the
volume of the sample was increased by 10% and the total number of the participants was
determined as 60. A total of 60 COPD patients treated with NIV in intensive care unit,
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 while the control group received routine nursing care. The inclusion criteria for
participants were: (a) a diagnosis of COPD (b) treated with NIV (c) be conscious of (d)
agreement to participate in the study and (e) COPD patients starting NIV therapy for the
first time. Patients who were intubated and therefore unable to speak, received sedation and
had a Glaskow Coma Scale score below 14 were excluded. There was no drop-out during the
study.
Data collection tools Personal Information Form: The form, developed by the researchers,
included questions about age, gender, educational level, marital status, smoking, information
on COPD, nausea and vomiting, information on NIV use.
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 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. 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.
Richmond Agitation-Sedation Scale (RASS): RASS scale was developed by a multidisciplinary
team at Virginia Common Wealth University. 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.
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.
Intervention 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. Supportive nursing care was also
practiced to the patients in the experimental group by the researchers. Routine nursing care
was practiced to the control group in the intensive care clinic where the patients were
located.
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. The
content of the information leaflet consisted of topics that will facilitate patient
compliance to treatment, such as the introduction of equipment used in NIV treatment, the
intended use of NIV and its effects on the patient, what patients generally experience during
treatment, compliance problems in NIV, how the procedure will be performed, each procedure
the nurse will do and for what purpose, the duration of the treatment, what the patient can
and cannot do during the treatment, what kind of process will proceed if everything goes
well. As supportive care, patients were allowed to express their feelings and thoughts about
NIV treatment, an accepting and empathetic approach was shown to the patients, care was taken
to make eye contact while communicating, therapeutic touch technique was used, it was
explained how the patients could reach the nurse when needed, the environment was arranged,
each procedure performed was explained with its objectives, they were placed in a position
where they could see the clock, strategies that will make it easier for the patients to cope
during the treatment were determined and they were encouraged to do so (for example, some
patients wanted to read a book and some patients wanted to sleep), the patients were
encouraged to ask questions comfortably, it was stated that the treatment could be
interrupted for a while when they felt bad due to the mask, and it was ensured that the
patients met with their relatives during the visiting hours.
Data analysis The Statistical Package for Social Sciences (SPSS) 20.0 package program was
used in the analysis of the data. Descriptive statistics were used as mean ± standard
deviation for variables with normal distribution, and median (min - max) for variables with
non-normal distribution. Nominal variables were shown as the number of patients (n) and (%).
The compliance of the data to normal distribution was examined with the Shapiro-Wilk test and
the homogeneity of the variances with the Levene test. For the comparison of the experimental
and control groups, Student's T test was used for data with normal distribution, Mann Whitney
U test was used for data with non-normal distribution. Chi-Square and Fisher's Exact tests
were used for group comparisons of nominal variables. "Analysis of Variance in Repeated
Measures" was used to analyze the values of the experimental and control groups before and
after the training in order to evaluate the effectiveness of the provision of information and
supportive nursing care intervention practised to the experimental group. In the analysis of
all tests, p value <0.05 was considered statistically significant.
