Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442813
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-01-12
Brief Title:
Effects Of Emotional Freedom Technique and Hypermesis Gravidarum
Sponsor:
Bezmialem Vakif University
Organization:
Bezmialem Vakif University
Study Overview
Official Title:
Effects Of Emotional Freedom Technique and Hypermesis Gravidarum
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
PREGNANCY
Brief Summary:
The purpose of this clinical study is to determine whether EFT Emotional Freedom Techniques is effective in alleviating nausea and vomiting in pregnant women with hyperemesis Additionally the study aims to gather information on the safety of EFT application The primary questions it seeks to answer are
Does EFT reduce nausea and vomiting in pregnant women with hyperemesis Is EFT applicable for use in pregnant women with hyperemesis Researchers will compare the effectiveness of EFT to traditional nursing education on non-pharmacological interventions for preventing nausea and vomiting in pregnant women with hyperemesis
Participants
Pre-EFT application survey scale questions will be asked to the pregnant women with hyperemesis
EFT will be applied once by the researcher to the pregnant women with hyperemesis
For control the same survey scale questions will be asked to the same pregnant women two days after the EFT application for post-test purposes
For control the same survey scale questions will be asked to the same pregnant women seven days after the EFT application for post-test purposes
The same procedures will be applied in the same manner to the control group that will receive education
Does EFT reduce nausea and vomiting in pregnant women with hyperemesis Is EFT applicable for use in pregnant women with hyperemesis Researchers will compare the effectiveness of EFT to traditional nursing education on non-pharmacological interventions for preventing nausea and vomiting in pregnant women with hyperemesis
Participants
Pre-EFT application survey scale questions will be asked to the pregnant women with hyperemesis
EFT will be applied once by the researcher to the pregnant women with hyperemesis
For control the same survey scale questions will be asked to the same pregnant women two days after the EFT application for post-test purposes
For control the same survey scale questions will be asked to the same pregnant women seven days after the EFT application for post-test purposes
The same procedures will be applied in the same manner to the control group that will receive education
Detailed Description:
Type of Research It is planned to be randomized controlled and experimental Place and Characteristics of the Research The research will be carried out in the women health and diseases service and Gynecology polyclinics of Bezmialem Vakif University Faculty of Medicine Central Hospital
Population and Sample of the ResearchThe sample size was determined as a minimum of 74 people in total using the G Power 31 method The effect size was determined using the t test values in the reference study in which the scale was used with a similar patient group
Criteria for Inclusion in the StudyPregnant women who are between 6 and 14 weeks of gestation aged between 20 and 40 years old and have complaints of nausea and vomiting are eligible for the study These participants should report their discomfort as 5 or above on the VAS scale Additionally they must not have been diagnosed with a high-risk pregnancy or any psychological disorders Lastly they must voluntarily agree to participate in the study
Criteria for Exclusion from the Study Exclusion criteria are the presence of coordination and language problems in the pregnant woman and her desire to leave the study at any time or not to participate
Survey Scales Descriptive Information Form The pregnancy information form prepared in line with the literature review conducted by the researchers includes socio-demographic age of the pregnant woman education and employment status income level family type and place of residence obstetric current gestational week and pregnancy history psychosocial information It consists of questions about social and medical history pregnancy desire whether there is a chronic disease and VAS Scale VAS is a measurement tool used to measure both pain intensity and pain relief which is simple effective and repeatable and requires minimal tools
2 Pregnancy-Specific Nausea and Vomiting Severity Scale PUQE-24 its form specific to the pregnancy period that evaluates nausea and vomiting for the last 12 hours It was later reported that it would be more appropriate to evaluate the last 24 hours for clinical use as the last 12 hours sometimes include the sleep period in terms of nausea and vomiting in pregnant women Thereupon the Pregnancy-Unique Quantification of Emesis PUQE-24 Scale was developed and evaluate the severity of pregnancy-specific nausea and vomiting in the last 24 hours Its Turkish validity and reliability were conducted
Pregnancy-Specific Nausea and Vomiting Severity Scale PUQE-24 consists of 3 questionsduration of nausea or stomach discomfort number of vomiting episodes and number of retching episodes Answers to the questions are scored between 1 and 5 points The total score of the scale is obtained by the sum of the scores of the answers given to the questions The lowest possible score that can be obtained from the scale is 3 and the highest score is 15 If the total score obtained as a result of the PUQE-24 scoring system is 3-6 it is considered mild 7-12 is considered moderate and 13-15 is considered severe nausea and vomiting The scale has no subdimensions Cronbacha alpha value of the Turkish version of the scale is 075
3World Health Organization Quality of Life Scale The WHOQOL-100 scale was developed with the participation of 15 centers from many countries This scale allows cross-cultural comparisons WHOQOL-100 was later abbreviated as WHOQOLBREF WHOQOL-BREF consists of four sub-dimensions physical domain spiritual domain social domain and environmental domain The validity and reliability of the World Health Organization Quality of Life Scale 31 Short Form-Turkish Version WHOQOL-BREF-TR in Turkey was determined WHOQOL-BREF-TR used in this study consists of 27 questions For each question there are options that can be scored between 1 and 5 The scale does not have a total score The score range that can be obtained from each other sub-dimension is obtained by multiplying the arithmetic mean of that sub-dimension by 4 The score range that can be received for each sub-dimension is between 4-20 Increasing scores from the subscales indicate that the quality of life also increases
Population and Sample of the ResearchThe sample size was determined as a minimum of 74 people in total using the G Power 31 method The effect size was determined using the t test values in the reference study in which the scale was used with a similar patient group
Criteria for Inclusion in the StudyPregnant women who are between 6 and 14 weeks of gestation aged between 20 and 40 years old and have complaints of nausea and vomiting are eligible for the study These participants should report their discomfort as 5 or above on the VAS scale Additionally they must not have been diagnosed with a high-risk pregnancy or any psychological disorders Lastly they must voluntarily agree to participate in the study
Criteria for Exclusion from the Study Exclusion criteria are the presence of coordination and language problems in the pregnant woman and her desire to leave the study at any time or not to participate
Survey Scales Descriptive Information Form The pregnancy information form prepared in line with the literature review conducted by the researchers includes socio-demographic age of the pregnant woman education and employment status income level family type and place of residence obstetric current gestational week and pregnancy history psychosocial information It consists of questions about social and medical history pregnancy desire whether there is a chronic disease and VAS Scale VAS is a measurement tool used to measure both pain intensity and pain relief which is simple effective and repeatable and requires minimal tools
2 Pregnancy-Specific Nausea and Vomiting Severity Scale PUQE-24 its form specific to the pregnancy period that evaluates nausea and vomiting for the last 12 hours It was later reported that it would be more appropriate to evaluate the last 24 hours for clinical use as the last 12 hours sometimes include the sleep period in terms of nausea and vomiting in pregnant women Thereupon the Pregnancy-Unique Quantification of Emesis PUQE-24 Scale was developed and evaluate the severity of pregnancy-specific nausea and vomiting in the last 24 hours Its Turkish validity and reliability were conducted
Pregnancy-Specific Nausea and Vomiting Severity Scale PUQE-24 consists of 3 questionsduration of nausea or stomach discomfort number of vomiting episodes and number of retching episodes Answers to the questions are scored between 1 and 5 points The total score of the scale is obtained by the sum of the scores of the answers given to the questions The lowest possible score that can be obtained from the scale is 3 and the highest score is 15 If the total score obtained as a result of the PUQE-24 scoring system is 3-6 it is considered mild 7-12 is considered moderate and 13-15 is considered severe nausea and vomiting The scale has no subdimensions Cronbacha alpha value of the Turkish version of the scale is 075
3World Health Organization Quality of Life Scale The WHOQOL-100 scale was developed with the participation of 15 centers from many countries This scale allows cross-cultural comparisons WHOQOL-100 was later abbreviated as WHOQOLBREF WHOQOL-BREF consists of four sub-dimensions physical domain spiritual domain social domain and environmental domain The validity and reliability of the World Health Organization Quality of Life Scale 31 Short Form-Turkish Version WHOQOL-BREF-TR in Turkey was determined WHOQOL-BREF-TR used in this study consists of 27 questions For each question there are options that can be scored between 1 and 5 The scale does not have a total score The score range that can be obtained from each other sub-dimension is obtained by multiplying the arithmetic mean of that sub-dimension by 4 The score range that can be received for each sub-dimension is between 4-20 Increasing scores from the subscales indicate that the quality of life also increases
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MMeseduzu | OTHER | BezmialemVU | None |