AcupressureNCT05420883
The Effect of Acupressure and Halogen Light Stimulation on Nonstress Testing and Pregnant Anxiety
A study testing Acupressure and Halojen ışık in people with Acupressure, run by Ondokuz Mayıs University.
Trial summary
Fetal death accounts for approximately half of perinatal death. Fetal health should be evaluated in order to identify fetuses at risk of intrauterine death and to prevent perinatal morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acupressure
- What is being tested?
- Acupressure and Halojen ışık
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those between the ages of 18-35,
- Gestational week of 34 and above,
- Single and live pregnancy,
- Number of births ≤3
- Having had Nonstress test at least once before,
- Having regular antenatal follow-up,
Show all 13Show fewer
- Able to speak and understand Turkish,
- Pregnant women with at least primary school graduates will be included in the study.
- Eating at least two hours before the nonstress test,
- Not using cigarettes, alcohol or drugs at least two hours before the Nonstress test,
- Not doing vigorous activity at least two hours before the Nonstress test,
- Urinating just before the Nonstress test,
- Basal heart rate is 110-160 beats per minute.
Who cannot join
- Having more than one pregnancy loss,
- Uterine contraction as a result of Nonstress test,
- In any situation that develops acutely during the Nonstress test,
- Those who could not complete the Nonstress test for any reason,
- Psychologically diagnosed (such as depression, schizophrenia)
- Any chronic disease (such as diabetes, hypertension, heart failure)
Show all 11Show fewer
- Pregnancy complications (such as preeclampsia, gestational diabetes, Rh incompatibility)
- Pregnant with a history of infertility and assisted reproductive techniques,
- A problem defined in the fetus (anomaly, intrauterine growth retardation and cardiovascular disease),
- Pre-pregnancy body mass index calculated as 30 and above,
- Pregnant women who give false or incomplete information will not be included in the study.
About this study
Official title: Effect of Acupressure and Halogen Light Stimulation on Nonstress Testing and Pregnant Anxiety: A Randomized Controlled Study
Fetal death accounts for approximately half of perinatal death. Fetal health should be evaluated in order to identify fetuses at risk of intrauterine death and to prevent perinatal morbidity and mortality. The Nonstress test, which is used to evaluate fetal health, is an important issue as it provides health professionals with information about fetal health. The research was planned as a randomized controlled trial to examine the effect of acupressure and halogen light stimulation on nonstress testing and anxiety of the pregnant woman. The research is planned to be conducted in the nonstress test room of the Obstetrics and Gynecology outpatient clinic of Samsun Training and Research Hospital Gynecology and Childhood Diseases Hospital between May 2021 and June 2023. The sample size of the study was calculated by power analysis (G*Power 3.1.9.2 program was used) and a total of 120 pregnant women were found. In order to increase the analysis power of the research, the number of samples was increased by 20% and it was decided to have at least 144 pregnant women (acupressure group: 48; halogen light group: 48 and control group: 48) for the study. The data of the study will be collected with the Pregnant Identification Form, the Nonstress Test Follow-up Form and the State Anxiety Scale. The data of the study will be evaluated using the SPSS 24 deviation, median and minimum-maximum values will be given. Chi-square test, Student t test, ANOVA test for those with normal distribution, Mann-Whitney U and Kruskal Wallis tests for those who are not.
Read the detailed description
H01: There was no difference between the nonstress test results of pregnant women who received acupressure and control group pregnant women.
H02: There was no difference between the anxiety levels of the pregnant women who received acupressure and the control group pregnant women.
H03: There is no difference between the nonstress test results of the pregnant women who received halogen light stimulation and the control group pregnant women.
H04: There was no difference between the anxiety levels of pregnant women who received halogen light stimulation and those in the control group.
H05: There is no difference between the nonstress test results of pregnant women who received acupressure and halogen light stimulation.
H06: There was no difference between the anxiety levels of pregnant women who received acupressure and halogen light stimulation.
This study was designed as a randomized controlled experimental study. The research will be carried out between May 2021 and June 2023 in the Nonstress test room in the obstetrics and gynecology outpatient clinic of Samsun Training and Research Hospital Gynecology and Childhood Diseases Hospital affiliated to Samsun Provincial Health Directorate. The universe of the study will be composed of pregnant women who applied to the Nonstress test room for Nonstress test extraction after having a pregnancy follow-up in the obstetrics and gynecology outpatient clinic of Samsun Training and Research Hospital. The sample of the study will be divided into three groups as acupressure group, halogen light group and control group.
The sample size of the study, according to the power analysis (G*Power 3.1.9.2 program was used) using the values of Rahimikian et al.'s (2013) studies, at least 40 people for each group (acupressure group: 40) with 80% power and 5% margin of error. ; halogen light group: 40 and control group: 40), a total of 120 pregnant women were calculated. In order to increase the analysis power of the research, the number of samples was increased by 20% and it was decided to have at least 144 pregnant women (acupressure group: 48; halogen light group: 48 and control group: 48) for the study. A layer will be formed in terms of age, number of pregnancies and gestational week of the pregnant women in the acupressure group, halogen light group and control group, and a homogeneous distribution of the groups will be ensured. Which group the participants will be in will be determined by the full randomization technique on the website www.randomizer.org. After obtaining permission from the ethics committee and the institution that will carry out the study, the pregnant women will go to the institution. Pregnant women who meet the research criteria will be informed about the purpose, content and method of the research, and verbal and written consent will be obtained from those who want to participate. The researcher will meet the pregnant women face to face and fill out the Pregnant Identification Form, the Nonstress Test Follow-up Form and the State Anxiety Scale.
Pregnant Identification Form: This form was developed by the researcher and consists of 20 questions, including 6 questions about the socio-demographic characteristics of pregnant women, 11 questions about their obstetric characteristics, and 3 questions about vital signs.
Nonstress Test Follow-up Form: This form was developed by the researcher and consists of a total of 16 questions, 7 questions that determine the thoughts of pregnant women about Nonstress Test and 9 questions about the findings related to Nonstress Test.
State Anxiety Inventory: The State and Trait Anxiety Inventory was developed by Spielberger et al. in 1970. The Turkish validity and reliability study of the scale was performed by Öner and Le Compte in 1985. The State Anxiety Inventory is a 20-item scale used to determine how an individual feels at a certain moment and under certain conditions. The scale can be administered to individuals over the age of 14 individually or in groups and takes an average of 10 minutes. The scores obtained from the scale theoretically vary between 20 and 80, with a large score indicating a high level of anxiety and a low score indicating a low level of anxiety.
Pre-Practice pre-study will be conducted with ten pregnant women before starting the study to evaluate whether the questions have been understood. As a result of the evaluation, it will be evaluated whether there is a need for editing in the data forms and adjustments will be made. Those included in the preliminary study will not be included in the sample group.
Pregnant women who came for the Nonstress test, met the inclusion criteria and volunteered to participate in the study will be informed about the study and an "Informed Consent Form" will be obtained from those who volunteered to participate in the study. Before starting the Nonstress test, the "Pregnant Identification Form" will be filled in by the researcher by interviewing the pregnant woman face to face. Before the procedure, one fruit juice will be drunk to prevent the difference between the eating times of the pregnant women. Then, the vital signs of the pregnant women will be taken and the fundus height, situs and position will be determined with the Leopold maneuvers by placing the pregnant women in the left lateral recumbent position. According to Leopold maneuver findings, a tocotransducer will be placed at the height of the fundus, and a transducer will be placed at the fetal ridge. Then, a 20-minute NST recording will be started by giving a marker to the pregnant woman's hand.
One minute after the Nonstress test recording starts, the acupressure group will be applied to the Zhi yin (BL67) acupuncture point with a depth of 0.1-0.2 cm, on the outer edge of the little toes of both feet, at the nail end point. The application will be applied to both points consecutively for 2 minutes at the same time and then a 3-minute rest period will be repeated 2 times. Successive pressures will be applied at a frequency that has a calming effect, so that the person is not disturbed or painful. After the nonstress test registration is completed, the State Anxiety Scale will be filled in by the pregnant woman, and the Nonstress Test Follow-up Form will be filled in by the researcher.
The halogen light group will be given halogen light stimulation for 10 seconds from the mother's abdomen to the fetal head one minute after the start of the twenty-minute Nonstress Test recording with a flashlight device (Vector VEC127Y 1 million candle power super sport spotlight with stand) worth 1,000,000 candles. The procedure will be repeated on the same spot 10 minutes after the first halogen light stimulation. After the nonstress test registration is completed, the State Anxiety Scale will be filled in by the pregnant woman, and the Nonstress Test Follow-up Form will be filled in by the researcher.
In the control group, no intervention will be made. The data of the study will be evaluated using the SPSS 24 (PASW Inc., Chicago. IL. USA) program. All data will first be evaluated with Kolmogorov-Smirnov for conformity to normal distribution and then analyzed according to fitness for normal distribution. For descriptive statistics, percentages will be used in general, arithmetic mean±standard deviation for those suitable for normal distribution, median and minimum-maximum values for those that do not fit. Chi-square test, student t test, ANOVA test for those with normal distribution, Mann-Whitney U and Kruskal Wallis tests for those who are not suitable will be used in the analysis of data. Type 1 error level will be taken as 0.05
- Conditions
- Acupressure
- Being tested
- Acupressure, Halojen ışık, Control
- Keywords
- Nonstress test, Anxiety, Halogen light, Acupressure
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
One minute after the Nonstress test recording starts, sequential pressure will be applied to the Zhi yin (BL67) acupuncture points simultaneously for 2 minutes. The process will be repeated a second time, with a three-minute rest period. After the 20-minute Nonstress test procedure, the test will be evaluated by the researcher and her anxiety will be determined.
Halojen ışıkOther
One minute after the start of the Nonstress test recording, halogen light stimulation will be given from the mother's abdomen over the fetal head for 10 seconds and the procedure will be repeated after 10 minutes. After the 20-minute Nonstress test procedure, the test will be evaluated by the researcher and her anxiety will be determined.
ControlOther
No application will be made to the control group. After the 20-minute Nonstress test procedure, the test will be evaluated by the researcher and her anxiety will be determined.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Active comparator | One minute after the start of the Nonstress test recording, an application will be made to the Zhi yin (BL67) acupuncture point with a depth of 0.1-0.2 cm, on the outer edge of the little toe of both feet, at the nail end point. The application will be applied to both points simultaneously for 2 minutes consecutively and then repeated 2 times with a 3-minute rest period. Receives: Other: Halojen ışık; Other: Control |
| Halogen light | Active comparator | One minute after the start of the Nonstress Test recording, halogen light stimulation will be given from the mother's abdomen to the fetal head for 10 seconds with a flashlight device worth 1,000,000 candles. The procedure will be repeated on the same spot 10 minutes after the first halogen light stimulation. Receives: Other: Acupressure; Other: Control |
| Control | Active comparator | No action will be taken against this group. Receives: Other: Acupressure; Other: Halojen ışık |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nonstress test result
The Nonstress test will be taken for 20 minutes and the result will be evaluated.
Measured: "on average 6 months when the study is complete"
Anxiety of the pregnant
It will be evaluated after the Nonstress test process.
Measured: "on average 6 months when the study is complete"
Secondary outcomes (2)
Nonstress test result
The Nonstress test will be taken and the result will be evaluated.
Measured: An evaluation will be made 20 minutes after the nonstress test process starts.
Anxiety of the pregnant
It will be evaluated after the Nonstress test process.
Measured: After 20 minutes of Nonstress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start15 Jun 2022 (estimated)
- Primary completion15 Nov 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcupressureStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Akupresür One minute after the start of the Nonstress test recording, an application will be made to the Zhi yin (BL67) acupuncture point with a depth of 0.1-0.2 cm, on the outer edge of the little toe of both feet, at the nail end point. The application will be applied to both points simultaneously for 2 minutes consecutively and then repeated 2 times with a 3-minute rest period. Halojen ışık One minute after the start of the Nonstress Test recording, halogen light stimulation will be given from the mother's abdomen to the fetal head for 10 seconds with a flashlight device worth 1,000,000 candles. The procedure will be repeated on the same spot 10 minutes after the first halogen light stimulation. Kontrol No action will be taken against this group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Collaborators
- Aydin Adnan Menderes University
- Responsible party
- Principal investigator, Yasemin Sökmen, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420883
- Sponsor's protocol ID
- d5uaw8rc
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rahimikian F, Rahiminia T, Modarres M, Mehran A. Comparison of halogen light and vibroacoustic stimulation on nonreactive fetal heart rate pattern. Iran J Nurs Midwifery Res. 2013 Mar;18(2):112-6.
PubMed 23983739
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure and Halogen Light Stimulation on Nonstress Testing and Pregnant Anxiety: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05420883
- Acronym / sponsor ID
- d5uaw8rc
- Conditions
- Acupressure
- Keywords
- Nonstress test, Anxiety, Halogen light, Acupressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Collaborators
- Aydin Adnan Menderes University
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fetal death accounts for approximately half of perinatal death. Fetal health should be evaluated in order to identify fetuses at risk of intrauterine death and to prevent perinatal morbidity and mortality. The Nonstress test, which is used to evaluate fetal health, is an important issue as it provides health professionals with information about fetal health. The research was planned as a randomized controlled trial to examine the effect of acupressure and halogen light stimulation on nonstress testing and anxiety of the pregnant woman. The research is planned to be conducted in the nonstress test room of the Obstetrics and Gynecology outpatient clinic of Samsun Training and Research Hospital Gynecology and Childhood Diseases Hospital between May 2021 and June 2023. The sample size of the study was calculated by power analysis (G*Power 3.1.9.2 program was used) and a total of 120 pregnant women were found. In order to increase the analysis power of the research, the number of samples was increased by 20% and it was decided to have at least 144 pregnant women (acupressure group: 48; halogen light group: 48 and control group: 48) for the study. The data of the study will be collected with the Pregnant Identification Form, the Nonstress Test Follow-up Form and the State Anxiety Scale. The data of the study will be evaluated using the SPSS 24 deviation, median and minimum-maximum values will be given. Chi-square test, Student t test, ANOVA test for those with normal distribution, Mann-Whitney U and Kruskal Wallis tests for those who are not.
Detailed description
H01: There was no difference between the nonstress test results of pregnant women who received acupressure and control group pregnant women.
H02: There was no difference between the anxiety levels of the pregnant women who received acupressure and the control group pregnant women.
H03: There is no difference between the nonstress test results of the pregnant women who received halogen light stimulation and the control group pregnant women.
H04: There was no difference between the anxiety levels of pregnant women who received halogen light stimulation and those in the control group.
H05: There is no difference between the nonstress test results of pregnant women who received acupressure and halogen light stimulation.
H06: There was no difference between the anxiety levels of pregnant women who received acupressure and halogen light stimulation.
This study was designed as a randomized controlled experimental study. The research will be carried out between May 2021 and June 2023 in the Nonstress test room in the obstetrics and gynecology outpatient clinic of Samsun Training and Research Hospital Gynecology and Childhood Diseases Hospital affiliated to Samsun Provincial Health Directorate. The universe of the study will be composed of pregnant women who applied to the Nonstress test room for Nonstress test extraction after having a pregnancy follow-up in the obstetrics and gynecology outpatient clinic of Samsun Training and Research Hospital. The sample of the study will be divided into three groups as acupressure group, halogen light group and control group.
The sample size of the study, according to the power analysis (G*Power 3.1.9.2 program was used) using the values of Rahimikian et al.'s (2013) studies, at least 40 people for each group (acupressure group: 40) with 80% power and 5% margin of error. ; halogen light group: 40 and control group: 40), a total of 120 pregnant women were calculated. In order to increase the analysis power of the research, the number of samples was increased by 20% and it was decided to have at least 144 pregnant women (acupressure group: 48; halogen light group: 48 and control group: 48) for the study. A layer will be formed in terms of age, number of pregnancies and gestational week of the pregnant women in the acupressure group, halogen light group and control group, and a homogeneous distribution of the groups will be ensured. Which group the participants will be in will be determined by the full randomization technique on the website www.randomizer.org. After obtaining permission from the ethics committee and the institution that will carry out the study, the pregnant women will go to the institution. Pregnant women who meet the research criteria will be informed about the purpose, content and method of the research, and verbal and written consent will be obtained from those who want to participate. The researcher will meet the pregnant women face to face and fill out the Pregnant Identification Form, the Nonstress Test Follow-up Form and the State Anxiety Scale.
Pregnant Identification Form: This form was developed by the researcher and consists of 20 questions, including 6 questions about the socio-demographic characteristics of pregnant women, 11 questions about their obstetric characteristics, and 3 questions about vital signs.
Nonstress Test Follow-up Form: This form was developed by the researcher and consists of a total of 16 questions, 7 questions that determine the thoughts of pregnant women about Nonstress Test and 9 questions about the findings related to Nonstress Test.
State Anxiety Inventory: The State and Trait Anxiety Inventory was developed by Spielberger et al. in 1970. The Turkish validity and reliability study of the scale was performed by Öner and Le Compte in 1985. The State Anxiety Inventory is a 20-item scale used to determine how an individual feels at a certain moment and under certain conditions. The scale can be administered to individuals over the age of 14 individually or in groups and takes an average of 10 minutes. The scores obtained from the scale theoretically vary between 20 and 80, with a large score indicating a high level of anxiety and a low score indicating a low level of anxiety.
Pre-Practice pre-study will be conducted with ten pregnant women before starting the study to evaluate whether the questions have been understood. As a result of the evaluation, it will be evaluated whether there is a need for editing in the data forms and adjustments will be made. Those included in the preliminary study will not be included in the sample group.
Pregnant women who came for the Nonstress test, met the inclusion criteria and volunteered to participate in the study will be informed about the study and an "Informed Consent Form" will be obtained from those who volunteered to participate in the study. Before starting the Nonstress test, the "Pregnant Identification Form" will be filled in by the researcher by interviewing the pregnant woman face to face. Before the procedure, one fruit juice will be drunk to prevent the difference between the eating times of the pregnant women. Then, the vital signs of the pregnant women will be taken and the fundus height, situs and position will be determined with the Leopold maneuvers by placing the pregnant women in the left lateral recumbent position. According to Leopold maneuver findings, a tocotransducer will be placed at the height of the fundus, and a transducer will be placed at the fetal ridge. Then, a 20-minute NST recording will be started by giving a marker to the pregnant woman's hand.
One minute after the Nonstress test recording starts, the acupressure group will be applied to the Zhi yin (BL67) acupuncture point with a depth of 0.1-0.2 cm, on the outer edge of the little toes of both feet, at the nail end point. The application will be applied to both points consecutively for 2 minutes at the same time and then a 3-minute rest period will be repeated 2 times. Successive pressures will be applied at a frequency that has a calming effect, so that the person is not disturbed or painful. After the nonstress test registration is completed, the State Anxiety Scale will be filled in by the pregnant woman, and the Nonstress Test Follow-up Form will be filled in by the researcher.
The halogen light group will be given halogen light stimulation for 10 seconds from the mother's abdomen to the fetal head one minute after the start of the twenty-minute Nonstress Test recording with a flashlight device (Vector VEC127Y 1 million candle power super sport spotlight with stand) worth 1,000,000 candles. The procedure will be repeated on the same spot 10 minutes after the first halogen light stimulation. After the nonstress test registration is completed, the State Anxiety Scale will be filled in by the pregnant woman, and the Nonstress Test Follow-up Form will be filled in by the researcher.
In the control group, no intervention will be made. The data of the study will be evaluated using the SPSS 24 (PASW Inc., Chicago. IL. USA) program. All data will first be evaluated with Kolmogorov-Smirnov for conformity to normal distribution and then analyzed according to fitness for normal distribution. For descriptive statistics, percentages will be used in general, arithmetic mean±standard deviation for those suitable for normal distribution, median and minimum-maximum values for those that do not fit. Chi-square test, student t test, ANOVA test for those with normal distribution, Mann-Whitney U and Kruskal Wallis tests for those who are not suitable will be used in the analysis of data. Type 1 error level will be taken as 0.05
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Akupresür One minute after the start of the Nonstress test recording, an application will be made to the Zhi yin (BL67) acupuncture point with a depth of 0.1-0.2 cm, on the outer edge of the little toe of both feet, at the nail end point. The application will be applied to both points simultaneously for 2 minutes consecutively and then repeated 2 times with a 3-minute rest period. Halojen ışık One minute after the start of the Nonstress Test recording, halogen light stimulation will be given from the mother's abdomen to the fetal head for 10 seconds with a flashlight device worth 1,000,000 candles. The procedure will be repeated on the same spot 10 minutes after the first halogen light stimulation. Kontrol No action will be taken against this group.
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Active comparator | Other: Halojen ışık, Other: ControlOne minute after the start of the Nonstress test recording, an application will be made to the Zhi yin (BL67) acupuncture point with a depth of 0.1-0.2 cm, on the outer edge of the little toe of both feet, at the nail end point. The application will be applied to both points simultaneously for 2 minutes consecutively and then repeated 2 times with a 3-minute rest period. |
| Halogen light | Active comparator | Other: Acupressure, Other: ControlOne minute after the start of the Nonstress Test recording, halogen light stimulation will be given from the mother's abdomen to the fetal head for 10 seconds with a flashlight device worth 1,000,000 candles. The procedure will be repeated on the same spot 10 minutes after the first halogen light stimulation. |
| Control | Active comparator | Other: Acupressure, Other: Halojen ışıkNo action will be taken against this group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Those between the ages of 18-35,
- Gestational week of 34 and above,
- Single and live pregnancy,
- Number of births ≤3
- Having had Nonstress test at least once before,
Key exclusion criteria (11 listed)
- Having more than one pregnancy loss,
- Uterine contraction as a result of Nonstress test,
- In any situation that develops acutely during the Nonstress test,
- Those who could not complete the Nonstress test for any reason,
- Psychologically diagnosed (such as depression, schizophrenia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureOne minute after the Nonstress test recording starts, sequential pressure will be applied to the Zhi yin (BL67) acupuncture points simultaneously for 2 minutes. The process will be repeated a second time, with a three-minute rest period. After the 20-minute Nonstress test procedure, the test will be evaluated by the researcher and her anxiety will be determined. | Other | Control, Halogen light |
| Halojen ışıkOne minute after the start of the Nonstress test recording, halogen light stimulation will be given from the mother's abdomen over the fetal head for 10 seconds and the procedure will be repeated after 10 minutes. After the 20-minute Nonstress test procedure, the test will be evaluated by the researcher and her anxiety will be determined. | Other | Acupressure, Control |
| ControlNo application will be made to the control group. After the 20-minute Nonstress test procedure, the test will be evaluated by the researcher and her anxiety will be determined. | Other | Acupressure, Halogen light |
Primary outcome
Nonstress test result
Time frame: "on average 6 months when the study is complete"
The Nonstress test will be taken for 20 minutes and the result will be evaluated.
Anxiety of the pregnant
Time frame: "on average 6 months when the study is complete"
It will be evaluated after the Nonstress test process.
2 secondary outcomes
Nonstress test result
Time frame: An evaluation will be made 20 minutes after the nonstress test process starts.
Anxiety of the pregnant
Time frame: After 20 minutes of Nonstress test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Background: PubMed 23983739Rahimikian F, Rahiminia T, Modarres M, Mehran A. Comparison of halogen light and vibroacoustic stimulation on nonreactive fetal heart rate pattern. Iran J Nurs Midwifery Res. 2013 Mar;18(2):112-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and Halojen ışık in people with Acupressure, run by Ondokuz Mayıs University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nonstress test result (time frame: "on average 6 months when the study is complete"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.