Clinical trial NCT06057116: The Effect of Massage and Acupressure on Labor Pain
Official title: The Effect of Massage and Acupressure on Labor Pain and Birth Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Massage
acupressure
labor pain
birth satisfaction
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Visual Analog Skala-VAS
timeFrame: 1 year
Secondary outcomes:
measure: Birth Satisfaction Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çağla Taş
Study officials:
References: