search
Back to results

The Effect of Massage and Acupressure on Labor Pain (Neu)

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
massage
Sponsored by
Near East University, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring Massage, acupressure, labor pain, birth satisfaction

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

İnclusion: Having a single fetus, Expecting spontaneous birth, Without Pregnancy Composition, No systemic disease, Those who voluntarily agreed to participate in the research. Exclusion: With systemic disease multiple pregnancies People who do not want to participate in the research.

Sites / Locations

  • Çağla Taş

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

massage

acupressure

control group

Arm Description

Massage was applied to people who were hospitalized in the obstetrics ward of the pregnant woman, had a single fetus, awaiting spontaneous delivery, had no pregnancy complications, had no systemic disease, and agreed to voluntarily participate in the study.

Acupressure for pregnant women who are hospitalized in the obstetrics service, have a single fetus, expect spontaneous delivery, do not have pregnancy complications, do not have any systemic disease, and agree to voluntarily participate in the study.

No intervention was performed on the patients who were hospitalized in the obstetrics service of the pregnant woman, had a single fetus, awaiting spontaneous delivery, had no pregnancy complications, had no systemic disease, and agreed to voluntarily participate in the study.

Outcomes

Primary Outcome Measures

Visual Analog Skala-VAS
The VAS is a 10 cm long ruler drawn horizontally or vertically with the words "no pain" at one end and "unbearable pain" at the other end.

Secondary Outcome Measures

Birth Satisfaction Scale
The Birth Satisfaction Scale is a Likert-type scale consisting of 30 questions. The score that can be obtained from the scale varies between 30-150 points.

Full Information

First Posted
August 26, 2023
Last Updated
September 21, 2023
Sponsor
Near East University, Turkey
search

1. Study Identification

Unique Protocol Identification Number
NCT06057116
Brief Title
The Effect of Massage and Acupressure on Labor Pain
Acronym
Neu
Official Title
The Effect of Massage and Acupressure on Labor Pain and Birth Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Near East University, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Massage, acupressure, labor pain, birth satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized controlled trial
Masking
Investigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
massage
Arm Type
Experimental
Arm Description
Massage was applied to people who were hospitalized in the obstetrics ward of the pregnant woman, had a single fetus, awaiting spontaneous delivery, had no pregnancy complications, had no systemic disease, and agreed to voluntarily participate in the study.
Arm Title
acupressure
Arm Type
Experimental
Arm Description
Acupressure for pregnant women who are hospitalized in the obstetrics service, have a single fetus, expect spontaneous delivery, do not have pregnancy complications, do not have any systemic disease, and agree to voluntarily participate in the study.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention was performed on the patients who were hospitalized in the obstetrics service of the pregnant woman, had a single fetus, awaiting spontaneous delivery, had no pregnancy complications, had no systemic disease, and agreed to voluntarily participate in the study.
Intervention Type
Other
Intervention Name(s)
massage
Other Intervention Name(s)
Acupressure
Intervention Description
Massage and acupressure were applied when cervical dilatation was 3-4, 5-7 and 8-10 cm in latent active and transitional phases.
Primary Outcome Measure Information:
Title
Visual Analog Skala-VAS
Description
The VAS is a 10 cm long ruler drawn horizontally or vertically with the words "no pain" at one end and "unbearable pain" at the other end.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Birth Satisfaction Scale
Description
The Birth Satisfaction Scale is a Likert-type scale consisting of 30 questions. The score that can be obtained from the scale varies between 30-150 points.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
İnclusion: Having a single fetus, Expecting spontaneous birth, Without Pregnancy Composition, No systemic disease, Those who voluntarily agreed to participate in the research. Exclusion: With systemic disease multiple pregnancies People who do not want to participate in the research.
Facility Information:
Facility Name
Çağla Taş
City
Adana
ZIP/Postal Code
99000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Massage and Acupressure on Labor Pain

We'll reach out to this number within 24 hrs