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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05190913
Other study ID # TNKU-M.Metinoglu-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2021
Est. completion date July 13, 2023

Study information

Verified date October 2023
Source Namik Kemal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Today, the increase in the costs of applications in the health care system makes it difficult for easy and inexpensive methods to be used based on evidence. In this study, the episiotomy rate, episiotomy length, perineal pain at birth and postpartum period, perineal trauma, newborn 1st min. and 5 min. It was planned as a Randomized Controlled Experimental study to examine the effect of APGAR score on birth outcomes such as the duration of the first and second stages of labor and birth satisfaction. The universe of the research was carried out between December 2021-2022 in University Hospital and City Hospital Pregnant women at 38-42 weeks of gestation who are admitted to the maternity ward to give birth. Power analysis was performed using the GPower program in order to sample size. In determining the sample size, the article titled "The Effect of Perineal Massage During Labor in Nulliparous Women on Birth Comfort, Perineal Pain and Trauma" (Yaşar, 2019) was used. Considering the total mean scores of the GCS scale in intervention and control groups, Type 1 error amount was 0.01, test power was 0.99, and effect size was 1.1276841; The minimum required sample size was determined as 80 (40 interventions + 40 control groups) for the intervention and control groups. In line with these data, it was decided that the sample size would be 120 pregnant women who agreed to be in the study and met the inclusion criteria, 40 in the intervention-1 group to be given instrumental perineal massage, 40 in the intervention-2 group that would receive non-instrumental perineal massage, and 40 in the control group. Frequency and mean values will be used in the evaluation of descriptive data, and independent sample t-test, chi-square test, fisher chi-square test and ANOVA will be used in the analysis of data showing normal distribution. The Mann Whitney U test is planned to be used in the analysis of data that do not show normal distribution. Normal distribution in the analysis of the relationship between prenatal instrument perineal massage and GCS scores, quality of pain, length of episiotomy, condition of the perineal region, duration of the first and second stages of labor, total delivery time, APGAR 1st and 5th minute scores, and parameters related to postpartum satisfaction Pearson correlation test will be used. All the results will be evaluated at the 95% confidence interval, at the 0.05 significance level.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Instrumental perineal massage
In the active phase of labor, perineal massage will be performed with an instrument twice with an interval of one hour.
manual perineal massage
In the active phase of labor, manual perineal massage is performed twice an hour apart.

Locations

Country Name City State
Turkey Meryem Metinoglu Tekirdag Süleymanpasa

Sponsors (1)

Lead Sponsor Collaborator
Namik Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary Labor Evaluation Form Part I I. It will be applied in the latent phase of labor (cervical dilatation: 0-4 cm).
II.It will be applied in the active phase of labor (cervical dilatation: 4-8 cm).
III.Until two days after birth
The progression time of vaginal dilatation at birth may vary from person to person. For this reason, the questionnaire will be applied at the beginning of the birth process, before the vaginal dilatation is 4 cm.
Primary Visual analog scale Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain. The progression time of vaginal dilatation at birth may vary from person to person. For this reason, the questionnaire will be applied at the beginning of the birth process, before the vaginal dilatation is 4 cm.
Primary Labor Evaluation Form Part II It will be applied during the active period of labor (cervical dilatation: 5-8 cm).
II.It will be applied in the active phase of labor (cervical dilatation: 4-8 cm).
III.Until two days after birth
The progression time of vaginal dilatation at birth may vary from person to person. For this reason, the questionnaire will be applied at the beginning of the birth process, before the vaginal dilatation is 8 cm.
Primary Labor Evaluation Form Part III It will be applied within the first 48 hours after the birth is completed. This form is evaluated within 48 hours of postpartum
Primary REEDA Scale This scale includes five factors that indicate perineal wound healing. These; These are redness (redness), edema (edema), ecchymosis (ecchymosis), discharge (discharge), approximation (approaching wound ends). Each factor takes values between 0-3. A total REEDA score (0-15) is obtained by evaluating these five improvement factors. The lowest score is 0 points, the highest score is 15 points. Higher scores indicate more tissue trauma. The REEDA score is evaluated in the 48th hour after delivery.
Primary Birth satisfaction scale The original of the scale used to evaluate women's perceptions of birth satisfaction is 30 items and is a five-point Likert type. It consists of 3 main themes: quality of care, personal characteristics of women and stress experienced during childbirth. A minimum of 30 and a maximum of 150 points can be obtained from the scale. The higher the score, the higher the level of satisfaction. This form is evaluated postpartum 10th day.
Primary Visual analog scale It is a scale used to evaluate the severity of pain. participants are asked to mark or say the point on the line numbered from zero to 10 that corresponds to the pain.Zero points; While expressing no pain, 10 points indicates the most severe pain experienced. The VAS is evaluated postpartum10th day.
Secondary Visual analog scale Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain. The progression time of vaginal dilatation at birth may vary from person to person. For this reason, the questionnaire will be applied at the beginning of the birth process, before the vaginal dilatation is 8 cm.
Secondary Visual analog scale Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain. The VAS is evaluated within 48 hours of postpartum after delivery
Secondary REEDA Scale This scale includes five factors that indicate perineal wound healing. These; These are redness (redness), edema (edema), ecchymosis (ecchymosis), discharge (discharge), approximation (approaching wound ends). Each factor takes values between 0-3. A total REEDA score (0-15) is obtained by evaluating these five improvement factors. The lowest score is 0 points, the highest score is 15 points. Higher scores indicate more tissue trauma. The REEDA score is evaluated in the postpartum 10th day after delivery.
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