Labor PainNCT05676879
Ice Massage Applied to SP6 Point at Labor
A study testing Ice massage was applied to the SP6 points in people with Labor Pain and Labor Comfort, run by Balikesir University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Labor Comfort, Duration of Labor
- What is being tested?
- Ice massage was applied to the SP6 points
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- expected vaginal delivery
- single healthy fetus
- primipara
- in the first phase of the labor
Who cannot join
- multipara
- risky pregnancy
- child with complications
- multiple pregnancies
- premature delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ice Massage Applied to SP6 Point on Labor Pain, Labor Comfort, Labor Duration, and Anxiety
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.
Read the 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 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.
- Conditions
- Labor Pain, Labor Comfort, Duration of Labor, Anxiety
- Being tested
- Ice massage was applied to the SP6 points
- Keywords
- Labor Pain, SP6 Acupoint, Labor comfort, duration of labor, anxiety
- Medical subject headings
- Labor Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice massage was applied to the SP6 pointsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Ice massage was applied to the SP6 points |
| Control Group | No intervention | All the pregnant women, those in the control group, were provided with standard midwifery care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of labor pain by VAS
The scale was used in order to measure labor pain. It is made up of a vertical line ranging from 0 to 10 (Ferreira-Valente et al., 2011). 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).
Measured: immediately after the intervention
Secondary outcomes (1)
duration of labor
duration of active phase and transition phase of labor (4-10cm cervical dilatation)
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Dec 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya TÜRKMEN, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676879
- Sponsor's protocol ID
- BalıkesirK
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ice Massage Applied to SP6 Point on Labor Pain, Labor Comfort, Labor Duration, and Anxiety
- ClinicalTrials.gov ID
- NCT05676879
- Acronym / sponsor ID
- BalıkesirK
- Conditions
- Labor Pain, Labor Comfort, Duration of Labor, Anxiety
- Keywords
- Labor Pain, SP6 Acupoint, Labor comfort, duration of labor, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Ice massage was applied to the SP6 pointsIce 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. |
| Control Group | No intervention | –All the pregnant women, those in the control group, were provided with standard midwifery care. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- expected vaginal delivery
- single healthy fetus
- primipara
- in the first phase of the labor
Key exclusion criteria (5 listed)
- multipara
- risky pregnancy
- child with complications
- multiple pregnancies
- premature delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice massage was applied to the SP6 pointsIce 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. | Other | Intervention Group |
Primary outcome
severity of labor pain by VAS
Time frame: immediately after the intervention
The scale was used in order to measure labor pain. It is made up of a vertical line ranging from 0 to 10 (Ferreira-Valente et al., 2011). 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).
1 secondary outcome
duration of labor
Time frame: during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice massage was applied to the SP6 points in people with Labor Pain and Labor Comfort, run by Balikesir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of labor pain by VAS (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.