Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738551
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2023-01-23
Brief Title:
Non-pharmacolytic Method in Obese Pain and Anxiety
Sponsor:
Necmettin Erbakan University
Organization:
Necmettin Erbakan University
Study Overview
Official Title:
Obez Bireylerde Kan Alma esnasında Uygulanan Iki farklı Nonfarmakolojik yöntemin ağrı ve kaygı üzerine Etkisinin Incelenmesi Randomize kontrollü çalışma
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Access to the vascular access is difficult in obese patients Therefore vascular access can be challenging and worrying for obese individuals This strain causes pain and anxiety Different interventions can be applied to reduce the pain and anxiety felt One of them is the methods of distraction Among these methods chewing gum and using a stress ball can contribute positively to the pain and anxiety at the entrance to the vein in order to draw blood in obese individuals In addition these interventions may affect vital parameters It was aimed to evaluate the effects of chewing gum and using a stress ball during vascular access in obese individuals on pain level anxiety level and vital signs
Detailed Description:
It is a three-armed randomized controlled trial
Research QuestionsHypotheses
H1 There is a difference between the arterial blood pressure heart rate and oxygen saturation values of the groups H2 There is a difference between the state anxiety scores of the groups H3 There is a difference between the pain scores experienced by the groups
Type of Research
3 groups post-test Randomized controlled trial
Location and Features of the Research
The research will be completed in the outpatient blood collection unit of XXX hospital
The populaıon of the Research
The population of the research will be the patients who applied to the blood collection unit of XXX hospital
Sample of the Research
The sample of the research An effect size of 035 was calculated as 108 with a margin of error 005 and a power of 090
F tests - ANOVA Fixed effects omnibus one-way Analysis A priori Compute required sample size Input Effect size f 035 α err prob 005 Power 1-β err prob 090 Number of groups 3 Output Noncentrality parameter λ 132300000 Critical F 30828520 Numerator df 2 Denominator df 105 Total sample size 108 Actual power 09047332
Randomization A randomorg package program was used for randomization and a randomization table was created RandomOrg
In the study the patient the nurse who took blood and the researcher will not be blinded the people who made the randomization and statistics and the person who collected the data after the intervention will be blinded
Inclusion Criteria for Participants in the Study
Being over 18 years old
Having a body mass index of 30 and above
Giving blood for analyzes upon the request of the physician
Having the harmony of place and time
Willingness to participate in the research Exclusion criteria
Absence of vision and hearing problems
Presence of any disease that may affect pain perception
Having cognitive problems
Having a condition that prevents chewing gum
Having a condition that prevents him from using the stress ball
Data Collection Tools
Individual identification form Visual comparison scale VAS state anxiety inventory pulse oximeter sphygmomanometer tape measure Individual introduction form and initiative materials It is a form consisting of 12 questions prepared by researchers in accordance with the literature It includes the socio-demographic and health-related characteristics of individuals
VAS Visual Comparison Scale The scale consists of or vertical lines The scale is scaled to 10 cm100 mm Horizontal form will be used in this study A score of 0 on the scale in the assessment of pain indicates that there is no pain during the blood draw procedure and a score of 10 indicates unbearablevery severe pain
State Anxiety Inventory It was developed by Spielberg et al 1964 Öner and le Compte 1983 was adapted into Turkish It can measure state and trait anxiety separately a total of 40 items In this study only the 20-item section that measures state anxiety will be used It gives information about the individuals feelings only at that moment It is a four-point Likert-type scale It is evaluated as not at all somewhat a lot and completely with 1 2 3 and 4 points In the state anxiety scale items 1 2 5 8 10 11 15 16 19 and 20 are reversed items The scale scores between 20 and 80 with a high score indicating a high level of anxiety However since the scale is not calculated straight it is stated that the average score generally varies between 36-41 After subtracting the total score of the reverse scored items from the total score of the flat items the scales own constant constant value of 50 is added to this score The reliability Kurder-Richardson Alpha coefficient of the original version of the state anxiety scale was reported as 083-092 while the Turkish version was 094-096
Stress ball Stress ball to be used It is a 6 cm diameter soft-textured polyurethane ball disinfected with a surface disinfectant
Chewing gum The gum to be used is for all patients the same brand is an easy-to-chew sugar-free gum that does not contain sorbitol and xylitol Before the chewing gum was given to the patient the hands of the patient and the researcher were disinfected with hand disinfectant The gum was given to the patient in a package and he was allowed to open it himself
Sphygmomanometer sphygmomanometer will be used for measurements Pulse oximeter device Finger type pulse oximeter device will be used The probe of the device the hands of the patient and the researcher will be disinfected before and after each application
Implementation of the Research and Collection of Data
The consent of the individuals who met the inclusion criteria was obtained from the individuals who came to the blood collection outpatient clinic and which group they would be included in will be determined by the researcher by drawing lots First the introductory data of the individual will be collected with the introduction form and the arm diameter will be measured Then the initiative will be applied according to which group it will take place in
Experiment 1 stress ball The patient will be asked to squeeze and loosen the stress ball with his non intervention hand for 5 minutes before and during the blood collection procedure The researcher will continue to observe the patient to ensure that the stress ball is used throughout the blood collection procedure After the blood collection procedure is completed the patient will be referred to a nurse independent of the study to measure the patients vital signs blood pressure pulse rate SPO2 measurement and filling out the pain and anxiety scale The nurse who made the last measurements will not know which group the patient is in The nurse who made the final measurements will be blind
Experiment 2 Chewing gum The patient will be given an unopened package of chewing gum and will be asked to chew the gum before and during the blood collection procedureChewing gum will take a total of 5 minutes During this process it will be observed by the researcher that the patient continues to chew gumAfter the blood collection procedure is completed the patient will be referred to a nurse independent of the study to measure the patients vital signs blood pressure pulse rate SPO2 measurement and filling out the pain and anxiety scale The nurse who made the last measurements will not know which group the patient is in The nurse who made the final measurements will be blind
Control group Introductory form and introductory data will be obtained from the individuals they will be directed to the bloodletting nurse without any application The same practices will be applied to the other two groups
blood collection procedure
Blood collection procedures will be done by a single nurse working in the blood collection unit It will be ensured that the same nurse performs the intervention of all groups in order to avoid differences in the intervention due to the person performing the procedure
Blood collection will be done from the antecubital vein of the right or left arm in all patients
After the application area is wiped with 70 alcohol and asepsis is achieved blood will be drawn
Patients who will receive blood are individuals who come to donate blood at the request of a physician Patients will not be subjected to any interventions such as taking extra blood getting an examination etc for this research
In all applications due to the Covid-19 process attention will be paid to the use of masks and hand hygiene ventilation of the environment and distance
Distribution of the research Obtaining permissions for research Hilal Türkben Polat collection of data and the implementation of the initiative Hilal Türkben Polat and Rukiye Burucu introduction and method Rukiye Burucu Hilal TÜRKBEN POLAT findings and discussion Hilal Türkben Polat Rukiye BURUCU
Variables of the Study Dependent variables Patient Post-procedure arterial blood pressure heart rate peripheral oxygen saturation pain score state anxiety score
Independent variables Patient age gender body mass index BMI education level marital status employment status income level chronic disease status Ethical Dimension of Research Research permission was obtained from the XXX Ethics Committee 04022022 20223640 and application permission was obtained from XXX Hospital 25112022 E-14567952-900-273749
Limitations of the Research The limitation of the study is that the data of the study are collected from patients followed only in one center in Konya
Evaluation of research data Statistics of the research will be done in SPSS 22 program The data will be summarized as number percentage mean and standard deviation chi-square analysis will be used to compare the sociodemographic characteristics of the experimental and control groups and t-test for independent groups will be used for the means The effect size obtained as a result of the calculations will be considered as 020 weak if it is between 020d080 medium and d080 large effect size The relationship between the scores will be examined by pearson correlation analysis r025 is very weak in the evaluation of the correlation 026 r 049 weak 050 r 069 medium 070 r 089 strong If 090 r 1 it will be considered very strong
Research QuestionsHypotheses
H1 There is a difference between the arterial blood pressure heart rate and oxygen saturation values of the groups H2 There is a difference between the state anxiety scores of the groups H3 There is a difference between the pain scores experienced by the groups
Type of Research
3 groups post-test Randomized controlled trial
Location and Features of the Research
The research will be completed in the outpatient blood collection unit of XXX hospital
The populaıon of the Research
The population of the research will be the patients who applied to the blood collection unit of XXX hospital
Sample of the Research
The sample of the research An effect size of 035 was calculated as 108 with a margin of error 005 and a power of 090
F tests - ANOVA Fixed effects omnibus one-way Analysis A priori Compute required sample size Input Effect size f 035 α err prob 005 Power 1-β err prob 090 Number of groups 3 Output Noncentrality parameter λ 132300000 Critical F 30828520 Numerator df 2 Denominator df 105 Total sample size 108 Actual power 09047332
Randomization A randomorg package program was used for randomization and a randomization table was created RandomOrg
In the study the patient the nurse who took blood and the researcher will not be blinded the people who made the randomization and statistics and the person who collected the data after the intervention will be blinded
Inclusion Criteria for Participants in the Study
Being over 18 years old
Having a body mass index of 30 and above
Giving blood for analyzes upon the request of the physician
Having the harmony of place and time
Willingness to participate in the research Exclusion criteria
Absence of vision and hearing problems
Presence of any disease that may affect pain perception
Having cognitive problems
Having a condition that prevents chewing gum
Having a condition that prevents him from using the stress ball
Data Collection Tools
Individual identification form Visual comparison scale VAS state anxiety inventory pulse oximeter sphygmomanometer tape measure Individual introduction form and initiative materials It is a form consisting of 12 questions prepared by researchers in accordance with the literature It includes the socio-demographic and health-related characteristics of individuals
VAS Visual Comparison Scale The scale consists of or vertical lines The scale is scaled to 10 cm100 mm Horizontal form will be used in this study A score of 0 on the scale in the assessment of pain indicates that there is no pain during the blood draw procedure and a score of 10 indicates unbearablevery severe pain
State Anxiety Inventory It was developed by Spielberg et al 1964 Öner and le Compte 1983 was adapted into Turkish It can measure state and trait anxiety separately a total of 40 items In this study only the 20-item section that measures state anxiety will be used It gives information about the individuals feelings only at that moment It is a four-point Likert-type scale It is evaluated as not at all somewhat a lot and completely with 1 2 3 and 4 points In the state anxiety scale items 1 2 5 8 10 11 15 16 19 and 20 are reversed items The scale scores between 20 and 80 with a high score indicating a high level of anxiety However since the scale is not calculated straight it is stated that the average score generally varies between 36-41 After subtracting the total score of the reverse scored items from the total score of the flat items the scales own constant constant value of 50 is added to this score The reliability Kurder-Richardson Alpha coefficient of the original version of the state anxiety scale was reported as 083-092 while the Turkish version was 094-096
Stress ball Stress ball to be used It is a 6 cm diameter soft-textured polyurethane ball disinfected with a surface disinfectant
Chewing gum The gum to be used is for all patients the same brand is an easy-to-chew sugar-free gum that does not contain sorbitol and xylitol Before the chewing gum was given to the patient the hands of the patient and the researcher were disinfected with hand disinfectant The gum was given to the patient in a package and he was allowed to open it himself
Sphygmomanometer sphygmomanometer will be used for measurements Pulse oximeter device Finger type pulse oximeter device will be used The probe of the device the hands of the patient and the researcher will be disinfected before and after each application
Implementation of the Research and Collection of Data
The consent of the individuals who met the inclusion criteria was obtained from the individuals who came to the blood collection outpatient clinic and which group they would be included in will be determined by the researcher by drawing lots First the introductory data of the individual will be collected with the introduction form and the arm diameter will be measured Then the initiative will be applied according to which group it will take place in
Experiment 1 stress ball The patient will be asked to squeeze and loosen the stress ball with his non intervention hand for 5 minutes before and during the blood collection procedure The researcher will continue to observe the patient to ensure that the stress ball is used throughout the blood collection procedure After the blood collection procedure is completed the patient will be referred to a nurse independent of the study to measure the patients vital signs blood pressure pulse rate SPO2 measurement and filling out the pain and anxiety scale The nurse who made the last measurements will not know which group the patient is in The nurse who made the final measurements will be blind
Experiment 2 Chewing gum The patient will be given an unopened package of chewing gum and will be asked to chew the gum before and during the blood collection procedureChewing gum will take a total of 5 minutes During this process it will be observed by the researcher that the patient continues to chew gumAfter the blood collection procedure is completed the patient will be referred to a nurse independent of the study to measure the patients vital signs blood pressure pulse rate SPO2 measurement and filling out the pain and anxiety scale The nurse who made the last measurements will not know which group the patient is in The nurse who made the final measurements will be blind
Control group Introductory form and introductory data will be obtained from the individuals they will be directed to the bloodletting nurse without any application The same practices will be applied to the other two groups
blood collection procedure
Blood collection procedures will be done by a single nurse working in the blood collection unit It will be ensured that the same nurse performs the intervention of all groups in order to avoid differences in the intervention due to the person performing the procedure
Blood collection will be done from the antecubital vein of the right or left arm in all patients
After the application area is wiped with 70 alcohol and asepsis is achieved blood will be drawn
Patients who will receive blood are individuals who come to donate blood at the request of a physician Patients will not be subjected to any interventions such as taking extra blood getting an examination etc for this research
In all applications due to the Covid-19 process attention will be paid to the use of masks and hand hygiene ventilation of the environment and distance
Distribution of the research Obtaining permissions for research Hilal Türkben Polat collection of data and the implementation of the initiative Hilal Türkben Polat and Rukiye Burucu introduction and method Rukiye Burucu Hilal TÜRKBEN POLAT findings and discussion Hilal Türkben Polat Rukiye BURUCU
Variables of the Study Dependent variables Patient Post-procedure arterial blood pressure heart rate peripheral oxygen saturation pain score state anxiety score
Independent variables Patient age gender body mass index BMI education level marital status employment status income level chronic disease status Ethical Dimension of Research Research permission was obtained from the XXX Ethics Committee 04022022 20223640 and application permission was obtained from XXX Hospital 25112022 E-14567952-900-273749
Limitations of the Research The limitation of the study is that the data of the study are collected from patients followed only in one center in Konya
Evaluation of research data Statistics of the research will be done in SPSS 22 program The data will be summarized as number percentage mean and standard deviation chi-square analysis will be used to compare the sociodemographic characteristics of the experimental and control groups and t-test for independent groups will be used for the means The effect size obtained as a result of the calculations will be considered as 020 weak if it is between 020d080 medium and d080 large effect size The relationship between the scores will be examined by pearson correlation analysis r025 is very weak in the evaluation of the correlation 026 r 049 weak 050 r 069 medium 070 r 089 strong If 090 r 1 it will be considered very strong
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