Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06057116 |
| Other study ID # |
YDU/2022/105-1587 |
| Secondary ID |
YDU/2022/105-158 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
June 15, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Near East University, Turkey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This research was conducted in accordance with the experimental research design to determine
the effect of acupuncture and massage, which are non-pharmacological methods used in the
treatment of labor pain, on the latent, active and transition stages of the first stage of
labor. On labor pain and birth satisfaction. Burhan Nalbantoğlu State Hospital and Near East
Hospital. There are three groups in the research sample: acupuncture, massage and control
groups. A total of 66 people were reached, 22 people in each group. Massage and acupuncture
were applied to the intervention groups, while pregnant women in the control group were not
intervened other than routine hospital practices. Cervical dilatation was applied for 3-4,
5-7 and 8-10 cm, and massage was applied for 10 minutes each, for a total of 30 minutes. When
cervical dilatation was 3-4, 5-7 and 8-10 cm, acupressure was applied for 1 minute each. The
pain level perceived by the pregnant woman was evaluated with the Visual Comparison Scale
(VAS), and her satisfaction with the birth was evaluated with the Birth Satisfaction Scale
(DME). In comparing the Birth Satisfaction Scale scores and Postpartum Pain VAS Scores, the
normal distribution of the data was examined with the Kolmogorov-Smirnov test, Shapiro-Wilk
test and skewness-kurtosis values and it was determined that it showed a normal distribution,
ANOVA was applied. Tukey test was used in further analysis for comparisons. ANCOVA was
applied to compare the amount of pain changes at the beginning and end of the latent, active
and transition phases according to participant groups.
Description:
The research will be carried out at the Near East Hospital and Nicosia Burhan Nalbantoğlu
State Hospital, Gynecology Service. The research will be carried out experimentally, 2
experiments (massage group and acupressure group) and 1 control group will be formed. 95%
confidence for the study to be performed with statistically 90% power It was calculated that
22 pregnant women should be given acupressure, 22 pregnant women should be given acupressure
and 22 pregnant women should be in the control group with a 5% margin of error. sample size
G*Power (Version 3.1.9.2 for Mac) software was used for calculation. Of the pregnant women to
be included in the experimental groups; It is planned to be performed with women over the age
of 18 and under the age of 35 who are hospitalized in the Gynecology Service of the Near East
University Hospital, are at term, have a single fetus, are expected to have spontaneous
delivery, do not have pregnancy complications or systemic diseases, and agree to participate
in the study. With the volunteer participants who meet these conditions, the study will
continue until the number of births is completed. In order to reduce the pain experienced
during labor, acupressure will be applied in the first stage of labor, at the end of the
latent, active and transitional phases, cervical dilation will be applied for 30 minutes at
3-4, 5-7, 8-10 cm intervals.
In the study, the Visual Analog Scale (VAS) will be used in the evaluation of labor pain.
VAS; It is helpful in the broad definition of labor pain. VAS is a horizontally or vertically
drawn It is a 10 cm long ruler that says no pain at one end and excruciating pain at the
other end. It is thought to be the most appropriate scale among one-dimensional scales in
determining the severity of pain, since it gives quick results, is easy and understandable,
and is not guided by numbers. Visual Analog Scale is extremely simple, efficient, It is a
pain intensity measurement method that can be repeated and requires minimal tools. The Birth
Satisfaction Scale (DME) will be used to assess birth satisfaction. DME is a Likert-type
scale consisting of 30 questions. The score that can be obtained from the scale varies
between 30-150 points. As the score obtained from the scale increases, the satisfaction with
the birth increases. VAS scores will be evaluated a total of 3 times at all these stages to
assess pain. In the same way, the massage will be evaluated with the VAS score by applying it
for 30 minutes in 3 phases. Finally, by making sure that the woman is resting in the
postpartum period, a 30-item questionnaire was used to measure her satisfaction with her
birth experience.
"Birth Satisfaction Scale" will be filled. The original "Birth Satisfaction Scale (BSS)" was
developed in 2009 by Caroline Hollins. Turkish validity and reliability study was conducted
by Coşar Çetin F. et al. in 2015. Responses to this 5-point Likert-type scale; Strongly Agree
5; Agree 4; I'm undecided 3; disagree 2; Strongly Disagree Scoring as 1. In scale items; 4,
8, 12, 15, 16, 17, 19, 20, 21, 23, 25 and 29 are scored as reverse items. The total number of
points to be taken from the scale varies between 30 and 150 points. The sub-themes in the
scale were quality of care, birth environment, adequate support.
