The Effect of Acupressure and Halogen Light Stimulation on Nonstress Testing and Pregnant Anxiety

NCT05420883 | Unknown

• 1 other identifier: d5uaw8rc
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Acupressure

Keywords

Nonstress test; Anxiety; Halogen light; Acupressure

Outcome Measures

Primary Outcomes (2)

• Nonstress test result

  The Nonstress test will be taken for 20 minutes and the result will be evaluated.

  "on average 6 months when the study is complete"

• Anxiety of the pregnant

  It will be evaluated after the Nonstress test process.

  "on average 6 months when the study is complete"

Secondary Outcomes (2)

• Nonstress test result

  An evaluation will be made 20 minutes after the nonstress test process starts.

• Anxiety of the pregnant

  After 20 minutes of Nonstress test

Study Arms (3)

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.

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.

Other: Acupressure; Other: Control

Control

ACTIVE COMPARATOR

No action will be taken against this group.

Other: Acupressure; Other: Halojen ışık

Interventions

Acupressure OTHER

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.

Control; Halogen light

Halojen ışık OTHER

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.

Acupressure; Control

Control OTHER

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.

Acupressure; Halogen light

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead
• Aydin Adnan Menderes University: collaborator

Related Publications (1)

• 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.

  PMID: 23983739 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Acupressure group 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 ışık group 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. Kontrol Group 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 15, 2022
• Study Start: June 15, 2022
• Primary Completion: November 15, 2022
• Study Completion: December 15, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share