Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04834037
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2021-04-05
Brief Title:
Effect of Provision of Information and Supportive Nursing Care A Randomised Controlled Trial
Sponsor:
Ondokuz Mayıs University
Organization:
Ondokuz Mayıs University
Study Overview
Official Title:
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 A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Trial design and the participants A randomised controlled design was used between September-December 2019 This study has been approved B302ODM02008390 by an ethics committee In order to carry out the study an application permit 17186359-60402 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 31 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 005 power as 095 and the effect size as moderate 025 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 Cronbachs alpha values depression 081 anxiety 080 stress 075
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 patients 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 200 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 Students T test was used for data with normal distribution Mann Whitney U test was used for data with non-normal distribution Chi-Square and Fishers 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 005 was considered statistically significant
The sample size was determined using G Power 31 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 005 power as 095 and the effect size as moderate 025 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 Cronbachs alpha values depression 081 anxiety 080 stress 075
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 patients 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 200 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 Students T test was used for data with normal distribution Mann Whitney U test was used for data with non-normal distribution Chi-Square and Fishers 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 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None