Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05676879
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2022-12-22
Brief Title:
Ice Massage Applied to SP6 Point at Labor
Sponsor:
Balikesir University
Organization:
Balikesir University
Study Overview
Official Title:
The Effect of Ice Massage Applied to SP6 Point on Labor Pain Labor Comfort Labor Duration and Anxiety
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 GPower 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 590 184 in the ice massage group and 710 164 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 005 Power 091 df 98 The decrease observed in labor pain at 4-5 cm cervical dilatation compared to the control group had an impact size of 061
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 randomorg 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 1Absolutely Disagree 5Absolutely 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 072 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 1Almost Never 4Almost 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 individuals 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 dropmin 10IUml 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 dropmin
Participants The study sample size was calculated by using GPower 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 590 184 in the ice massage group and 710 164 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 005 Power 091 df 98 The decrease observed in labor pain at 4-5 cm cervical dilatation compared to the control group had an impact size of 061
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 randomorg 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 1Absolutely Disagree 5Absolutely 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 072 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 1Almost Never 4Almost 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 individuals 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 dropmin 10IUml 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 dropmin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None