Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05829473 |
| Other study ID # |
Hyperemesis Gravidarum |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 30, 2023 |
| Est. completion date |
August 15, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Gaziantep Islam Science and Technology University |
| Contact |
EMINE KARACAN, PhD |
| Phone |
+905300350414 |
| Email |
emine.karacan[@]iste.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Objective: The aim of the researchers is to determine the effects of guided imagery and
diaphragmatic breathing exercise application on nausea, vomiting severity, and anxiety level
in pregnant with hyperemesis gravidarum.
Methods: This study was planned as a single-blind randomized controlled experimental study.
It is planned to be conducted with 180 pregnant women to be randomized in a university
hospital in Southeastern Anatolia between April 2023 and August 2023. Data will be collected
using the "Descriptive Information Form", "Nausea-Vomiting Severity Assessment Test During
Pregnancy" and "Pregnancy-Related Anxiety Scale-R2".
Keywords: Anxiety, Hyperemesis Gravidarum, Nausea-Vomiting, Guided Imagery, Diaphragmatic
Breathing Exercise, Nursing,
Description:
1. INTRODUCTION AND OBJECTIVE Pregnancy-related nausea and vomiting are attacks that occur
in the first half of pregnancy, accompanied by occasional nausea and vomiting.
Hyperemesis gravidarum is a clinical picture of unknown etiology and without
standardization in its diagnosis and treatment. Hyperemesis gravidarum, on the other
hand, although not a universally accepted definition, can generally be defined as a
condition that causes a loss of 5% of the pre-pregnancy weight before the 20th
gestational week, with vomiting severe enough to require hospitalization. It usually
begins in early pregnancy (at 4-8 weeks) and lasts until the start of the second
trimester. Hyperemesis gravidarum is seen in approximately 0.3-2% of pregnancies and is
one of the most common causes of hospital admission in the first half of pregnancy.
In the treatment of hyperemesis gravidarum, there are many non-pharmacological treatment
methods as well as pharmacological methods. Alternatively, some non-pharmacological
applications can be used alone or in combination with drug therapy as an adjunctive
treatment option to control nausea and vomiting. These non-pharmacological methods;
diet, music therapy, daydreaming, and hypnosis. In addition to these applications, there
are also applications such as social support groups, regular exercise, vitamin drugs,
aromatherapy, yoga, ginger root tea, breathing exercises, acupuncture, and
reflexology/foot massage in controlling nausea and vomiting. Among these alternatives,
non-pharmacological treatment methods are breathing exercises and guided imagery. There
are studies showing that guided imagery and breathing exercise practices reduce stress
and anxiety in pregnant women, increase their well-being, are beneficial to their daily
lives, positively contribute to mother-baby bonding, and reduce pain in high-risk
pregnant women.
However, as a result of the literature review, it was seen that there was no study
investigating the effects of guided imagery and diaphragmatic breathing exercise on the
severity of nausea, vomiting, and anxiety level in pregnant women with hyperemesis
gravidarum. Therefore, the aim of the researchers is to determine the effects of guided
imagery and diaphragmatic breathing exercise application on nausea, vomiting severity,
and anxiety level in pregnant with hyperemesis gravidarum.
HYPOTHESES
The hypotheses of this study are:
H0: Diaphragmatic breathing exercises and guided imagery have no effect on nausea,
vomiting severity, and anxiety level in pregnant with hyperemesis gravidarum.
H1: Diaphragmatic breathing exercise reduces nausea and vomiting severity. H2:
Diaphragmatic breathing exercise reduces anxiety level. H3: Guided imagery reduces
nausea, vomiting severity H4: Guided imagery reduces anxiety levels.
2. MATERIAL AND METHODS 2.1. Study Design: This study was planned as a single-blind
randomized controlled experimental study.
2.2. Setting and Samples: The researchers planned to be done this study between December 2022
and December 2023 in the gynecology and obstetrics service, at the university hospital in
southeastern Anatolia, Turkey.
The sample size was assessed using G-power analysis (effect size 0.3; medium level α = 0.05;
1-β = 0.80), and it was found that for each group, 58 patients had the capability of
representing the population. However, we decided to include 60 pregnant women in each group
in order to be able to generalize and strengthen the research results.
2.2.1. Randomization: Medical version 18.11.3 will be used for the randomization list for
assigning participants to groups. Pregnant women participating in the study won't know how
many groups are available and which method will be applied to the group in which they are
selected. We will do this study with three groups, two experiments, and one control. The
experimental group will be divided into two groups, guided imagery, and breathing exercise
group.
2.3. Data Collection Tools: The data of the study will be collected by using ''The
Descriptive Information Form", "Nausea-Vomiting Severity Evaluation Test During Pregnancy ",
and "Pregnancy-Related Anxiety Scale- R2 ''.
2.3.1. The Descriptive Information Form: This form, which was developed by researchers
through a literature review, consists of three parts. In the first part, the age, education,
duration of the marriage, income status, etc. of pregnant women. 10 questions, including
socio-demographic characteristics such as; the second part includes the first gestational
age, the number of miscarriages, gestational week, expected delivery date, etc. including
obstetric features such as 7 questions; The third part consists of 2 questions evaluating the
satisfaction with the applications made to the intervention groups. The introductory
information form will be filled in by the researchers by communicating face-to-face on the
first day of hospitalization to the intervention and control groups.
2.3.2. Nausea-Vomiting Severity Evaluation Test During Pregnancy: The scale consists of 3
questions questioning nausea, vomiting, and retching, respectively. Although the symptoms
were initially questioned for the last 12 hours, it was later updated to cover the last 24
hours. When evaluating the Nausea-Vomiting Severity Evaluation test, the total score is
stated as mild if it is 3-6, moderate if 7-12, and severe nausea and vomiting if it is 13-15.
2.3.3. Pregnancy-Related Anxiety Scale- R2: It is a 5-point Likert scale. The 11-item scale
consists of "fear of childbirth (1, 2, 6, and 8th items)", "fear of having a disabled child
(4, 9, 10, and 11th)" and "concerns about physical appearance (3, 5 and 7). item)" has 3
sub-dimensions. The 8th item in the scale (I am worried about childbirth because I have never
given birth before) is used for women who have not given birth before but is not applied to
multiparous women. Items are scored between 1-5 (1-Strongly disagree and 5-Strongly agree)
and a minimum of 11 points and a maximum of 55 points are received for primiparas, and a
minimum of 10 and a maximum of 50 points are received for multiparas. As the score obtained
from the scale increases, it is accepted that the level of anxiety in pregnancy is higher.
All of the expressions in the scale are positive. The scale has no cut-off point. The
Cronbach's alpha coefficient of the scale was 0.93 for the multiparous group and 0.94 for the
primiparous group.
2.4. Data Collection: After the approval of the ethics committee and the application
permission of the research, the hospital head physician, head nurse, gynecology service
physicians, and nurses will be interviewed and information will be given about the purpose
and scope of the research. Data will be collected by the researcher. Pregnant women who
comply with the sampling selection criteria and agree to participate in the study will be
informed about the purpose of the research, the method of the research, the breathing
exercise and guided imagery method in accordance with the group they belong to, and the
hospital management and ethics in order to carry out the research, It will be explained that
permission has been obtained from the committee, that identity information is required for
research consent, that identity information will be kept confidential by the researcher, and
their consent will be obtained with a verbal and Informed Voluntary Consent Form.
Breathing Exercise Group: An introductory information form will be filled in after meeting
the pregnant women in the breathing exercise group admitted to the service at the first
interview, giving information about the method to be followed in the practice, and obtaining
their written consent. Since the hospitalization period of pregnant women hospitalized with
the diagnosis of hyperemesis gravidarum varies between 3 and 7 days, the pregnant women with
hyperemesis gravidarum who meet the research criteria are made 10 minutes once a day. A total
of 1 times day diaphragmatic breathing exercise will be made on 3 consecutive days (5 minutes
diaphragmatic breathing exercise, 5 minutes relaxation exercise). Diaphragmatic breathing
exercises will be performed at least 4 hours after the use of antiemetic drugs in the
service. Pre-test data will be obtained by using the Nausea-Vomiting Severity Assessment Test
in Pregnancy and Pregnancy-Related Anxiety Scale-R2 scales before the application. Afterward,
20 minutes from the application post-test data will be obtained by using the Nausea-Vomiting
Severity Assessment Test in Pregnancy and Pregnancy-Related Anxiety Scale-R2 scales. A total
of 6 measurements will be made using the Nausea-Vomiting Severity Assessment Test in
Pregnancy and Pregnancy-Related Anxiety Scale-R2 scales before and after the diaphragmatic
breathing exercises performed on the 1st, 2nd, and 3rd days.
Guided Imagery Group: An introductory information form will be filled in after meeting the
pregnant women in the guided imagery group admitted to the service at the first interview,
giving information about the method to be followed in the practice, and obtaining their
written consent. 10 minutes once a day for pregnant women with hyperemesis gravidarum who
meet the research criteria the guided imagery compact disc will be played with the computer.
A guided imagery compact disc will be watched at least 4 hours after the use of antiemetic
drugs in the service. Pre-test data will be obtained by using the Nausea-Vomiting Severity
Assessment Test in Pregnancy and Pregnancy-Related Anxiety Scale-R2 scales before the
application. Afterward, 20 minutes from the application post-test data will be obtained by
using the Nausea-Vomiting Severity Assessment Test in Pregnancy and Pregnancy-Related Anxiety
Scale-R2 scales. A total of 6 measurements will be made using the Nausea-Vomiting Severity
Assessment Test in Pregnancy and Pregnancy-Related Anxiety Scale-R2 scales before and after
the guided imagery compact disc application on the 1st, 2nd, and 3rd days.
Control Group: No intervention will be made to the pregnant women in the control group, other
than their routine daily care. Pre-test data will be obtained by applying the scales at least
4 hours after the use of antiemetic drugs in the service. 20 min from the pre-test data.
Afterward, the final test data will be obtained by applying the scales. A total of 6
measurements will be made using the Nausea-Vomiting Severity Assessment Test in Pregnancy and
Pregnancy-Related Anxiety Scale-R2 scales on the 1st, 2nd, and 3rd days.
2.5. Data Analysis: The data will analyze using Statistical Package for the Social Sciences
23.0 software. The analysis will be carried out by a statistician who was not included in the
study. Tables will give frequency distribution (number, percentage) for categorical variables
and descriptive statistics (median and quartiles, mean, standard deviation) for numerical
variables. Shapiro Wilk test will use for conformity to the normal distribution and it will
determine that numerical variables are not suitable for normal distribution. The
Kruskal-Wallis test will use to determine whether there is a difference between the groups in
terms of numerical measurements. In addition, Bonferroni correction will be applied while
checking again with the Mann-Whitney U test from which group or groups the difference
originated. The Chi-square test will be used to determine whether there is a difference
between the groups in terms of categorical measures. Correlation (Spearman's rho) analysis
will be conducted to see the direction and power of the correlation between variables. In
comparison, the confidence interval will be taken as 95%, and the p significance level will
accept as p < 0.05.
