Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05676879 |
| Other study ID # |
BalikesirK |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2021 |
| Est. completion date |
July 1, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Balikesir University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: In the study , it was aimed to determine the effect of ice massage applied to SP6
point during labor on labor pain, labor comfort, labor duration, and anxiety.
Design: A single blind, randomized controlled experimental trial Setting and Participants:
100 primiparas, 50 in the intervention group and 50 in the control group, with 4-5 cm
cervical dilatations were included in the study. Ice massage was applied to the SP6 point of
the pregnant women in the intervention group at 4-5 cm, 6-7 cm, and 8-9 cm dilatations during
three contractions.
Measurement Tools: The Pregnant Information Form, VAS, the Partograph Form, Childbirth
Comfort Questionnaire (CCQ), and the State Anxiety Scale were used to collect data.
Description:
The study was conducted as a randomized controlled trial in the Delivery Room of Ataturk City
Hospital located in Balikesir province of Turkey between December 2021 and July 2022.
Participants The study sample size was calculated by using G*Power 3 power calculations based
on previous studies in which ice massage was applied to acupressure points during labor.
Impact estimation was obtained from the findings of the study conducted by Hajiamini et al.,
who reported pain severity as 5.90 ± 1.84 in the ice massage group and 7.10 ± 1.64 in the
control group 30 minutes after the ice massage application. In the present study, it was
aimed to determine a similar difference. The sample size for each group was determined to be
at least 47 individuals. Accordingly, 50 primiparas were assigned to the intervention group
and the control group each. The power analysis performed showed that the sample size of the
study had a power as α = 0.05, Power = 0.91, df = 98. The decrease observed in labor pain at
4-5 cm cervical dilatation compared to the control group had an impact size of 0.61.
The inclusion criteria for the primiparas were having a single healthy fetus, having a
gestational age between 38 and 40 weeks, expecting vaginal delivery, having fetal cephalic
presentation, having no chronic diseases, not having a high-risk pregnancy, being in stage 1
of childbirth, and having a 4-5 cm cervical dilatation. Pregnant women who were multiparous,
had multiple pregnancies, had high-risk pregnancy, had delivery with complications, and came
to the clinic after 4-5 cm dilatation were excluded from the study.
Single blind block randomization for pregnant women who met the inclusion criteria was
achieved by using Sequence Generator method located under the subheading of Numbers at
random.org website. In the program, two columns were created according to the sample size.
The pregnant women were randomly assigned to Column 1 or Column 2 according to their
registration number. The assignment of the columns to either the intervention group or the
control group was done through a draw. Ice massage was applied to SP6 points of the pregnant
women in the intervention group, while the pregnant women in the control group was provided
with standard midwifery care.
Data collection The Pregnant Information Form (PIF), Visual Analog Scale (VAS-1), and
Childbirth Comfort Questionnaire (CCQ) were administered to the pregnant women who were at
stage 1 of delivery and 4-5 cm cervical dilatation. Each group was provided with standard
midwifery care, and intervention was made to the women in the intervention group at 4-5 cm,
6-7 cm, and 8-9 cm cervical dilatation during three contractions. Immediately after the
interventions, VAS-2, VAS-3, and VAS-4 were applied. In addition, following the intervention
made at 6-7 cm cervical dilatation, The State Anxiety Scale (STAI-I) was applied between the
contractions. After the interventions were completed, CCQ was applied again at 8-9 cm
cervical dilatation. The pregnant women in the control group were administered VAS-2, VAS-3,
and VAS-4 at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatations, STAI-I at 6-7 cm cervical
dilatation, and CCQ at 8-9 cm cervical dilatation.
Measurement tools The study data were collected through The Pregnant Information Form, VAS,
Partograph Form, Childbirth Comfort Scale, and the State Anxiety Scale.
The Pregnant Information Form (PIF): The form consists of 22 questions inquiring about the
sociodemographic, gynecological, and obstetric characteristics of the pregnant women.
Visual Analog Scale (VAS): The scale was used in order to measure labor pain. It is made up
of a vertical line ranging from 0 to 10. In the study, VAS was applied before the
intervention at 4-5 cm cervical dilatation (VAS-I) and after the intervention at 4-5 cm, 6-7
cm, and 8-9 cm cervical dilatations (VAS-2, VAS-3, VAS-4, respectively).
Childbirth Comfort Questionnaire (CCQ): The 9-item scale is a 5-point Likert type scale
(1=Absolutely Disagree, 5=Absolutely Agree). The score to be obtained from the scale ranges
between 9-45. A high score indicates a high level of comfort. In the present study, this
value for the scale was determined to be 0.72. CCQ was applied two times in the study, once
at 4-5 cm cervical dilatation before the intervention and once at 8-9 cm dilatation after the
intervention.
State Anxiety Scale (STAI-I): The 4-point Likert type scale (1=Almost Never, 4=Almost Always)
consists of 20 questions. There are two types of statements on the scale. Direct statements
express negative emotions, while reverse statements express positive emotions. Weighted total
score is calculated for both direct and reverse statements. The totals score obtained from
negative statements is subtracted from the total score obtained from positive statements. A
pre-determined constant number (50) is added to this number obtained. The final score
obtained is the individual's anxiety score. The scores obtained from the scale varies between
20 and 80. A high score shows a high level of anxiety.
Intervention Ice massage was applied to the SP6 points (SP6 point is located 3-4 fingers
above the posterior malleolus bone, that is, 4 fingers above the ankle) of the pregnant women
in first stage of childbirth at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatations during 3
contractions. In order to prevent direct contact of ice with the skin, ice was applied as ice
cubes wrapped in gauze. Standard midwifery care was provided to the women in both groups. In
the hospital where the study was conducted, cervical dilatation and effacement follow-up,
contraction and fetal heart rate follow-up, vital signs monitoring, and routine oxytocin
induction are applied as standard midwifery care. In addition, pregnant women are provided
with information on breathing and pushing techniques. 4 drop/min 10IU/ml oxytocin induction
was applied to all pregnant women in both groups at 4-5 cm cervical dilatation. Oxytocin
induction was increased by 4 drops at every 20 minutes. It was applied at a maximum dose of
40 drop/min.
