Effect of Social Support During Labor

NCT07539376 | Completed

• 1 other identifier: No.3/3/2021/2022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Problem Statement: In the governmental hospitals it is not allow to presence one of family with woman during child birth in labor room that affects negatively in pregnant emotion and feel more anxious especially primigravida although it effect positively in labor process and outcomes and providers have realized the benefit of having a social support with woman in labor room in facilities where there is a shortage of nurses and midwives (Kabakian-Khasholian and Portela,2017). On the other hand, there is evidence that the cyclic and upward spiraling relationship among fear, tension, and pain proposed by Dick-Read (2005) may account for escalating labor pain in that increased tension and anxiety during labor contribute to increased pain. An explanation is that excessive anxiety increases an endogenous release of catecholamine, which reduces blood flow to and from the placenta, restricts fetal oxygen supply and waste removal, reduces effectiveness of uterine contractions, and slows labor progress ((Yuenyong, O'Brien and Jirapeet, 2012) Significance of The Study: This is the first study of its kind in Jordan. Social support during labor has significance effect on birth outcomes of delivery on women and newborn in labor room. It leads to positive results for the mother and the newborn. The results of study will contribute to giving the birth process a masculine character, which leads to reducing the risks of childbirth and reducing newborn death (Anjos and Gouvesia,2019). Finding of this study will help policy members and health care provider to understand the importance of presence supporter with women in labor room, perhaps we can include this procedure with treatment and delivery plan, especially in the delivery rooms in government hospitals. Purpose: The purpose of this study is to find effect of presence social support with woman in labor room on birth outcomes in AL Basheer hospital. Research Question: What is the effects of presence social supporter with women in labor room during the first and the second stage of labor? Hypothesis: The result is expected to find positively effect of presence social support that chosen by pregnant woman to stay with her in labor room during child birth process. Method Design: An experimental, randomized control trial, pretest- posttest will be used in this study, the experimental design the most powerful design for testing cause and effect relationship due to control, manipulation and randomization (Polit, Beck and Polit, 2017), by randomizer the number from 1 to 150 will distributed into two group the first group, intervention group and the other one the control group. The participants will choose a sheet of paper from box with sheets numbered from 1 to 150 and define group according to number. Setting: The study will be conducted at Al Basheer governmental hospital in Amman that the family member not allowed to be with women during labor, special permission will be obtained for this study. In labor room in Al-Basheer hospital the room is divided into three sections, the first is the initial stage and contains 10 beds, each bed is separate from the other and contains a device to follow the baby's pulse in addition to other monitoring devices such as pressure and temperature device. The patient remains in this section until the dilatation becomes fully and moves to the most important section It contains three separate rooms and contains resuscitation devices for the baby this section is for the second stage of labor. When the patient finishes this stage, she goes to the last section, which contains 5 postpartum beds, and stays for two hours, and then moves to the postpartum department. In labor room there is two doctors and 4 or 5 midwives specialists in maternity. Sample: Target population: All pregnant woman in labor room Accessible population: Laboring women in first active stage of labor and low risk laboring. Sampling technique Sample size: A statistical power of 0.8 and a medium effect size of 0.5 will be used because the intervention in this study has not been tested before. In addition to the significance level will be 0.05. According that the sample size will be 120 pregnant women and divided into two group 60 women in intervention group and 60 in control group. Non-Probability Sampling Methods will be used Convenience sampling of pregnant women who is met the criteria in labor ward, Sample size will be estimated according to Cohen power analysis by using t-test, to attain power =0.8, significant level α = .05 (medium size effect), however, 20% will be added to overcome attrition the required sample size will be (N= 150), The convenience sampling appropriate for this study because it relies on available subjects such as patients in hospital (Polit, Beck and Polit, 2017) Introduction The labor process occurs in four successive stages. The first stage begins with regular uterine contractions until full dilation of the cervix.

Conditions

Labor Delivery; Maternal and Neonatal Outcomes

Outcome Measures

Primary Outcomes (2)

• satisfaction level

  The level of comfort experienced by the women during the childbirth process. Satisfaction in this case is described by how the midwives and caregivers handle women during their first and second stages of labor in addition to physical and emotional support, medical care, coping with labor pain, and health education.

  two days during labor and giving birth process

• anxiety level and pain intensity

  Anxiet is measurable quantity that describes the level of distress experienced by the women during the first and second stages of labor. Included 19 items that Addressed feelings of anxiety during intrapartum. Pain is Pain: the quantitatively measurable physical discomfort that comes as a result of labor among women. This study considers pain as a discomfort felt due to the physical process of childbirth.

  Two days during labor and giving birth process

Study Arms (2)

intervention

EXPERIMENTAL

group who will get the intervention that is presence of supportive person during labor.

Other: Supportive person during labor

control

NO INTERVENTION

group without the supportive pearson during labor and be given the standard care in labor room.

Interventions

Supportive person during labor OTHER

Presence of support female person in labor room during stages of labor

intervention

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• laboring woman (active phase)
• low-risk labor determines by obstetrician
• term pregnancy
• singleton fetus
• participant can read and write (at least primary level) of education.

You may not qualify if:

• High risk pregnancies
• pre term pregnancies
• obstructed labor
• intra uterine fetal death
• still birth
• in vitro fertilization
• twins pregnancy
• abnormalities in fetus
• with chronic disease
• psychological problem.

Sponsors & Collaborators

• The Hashemite University: lead

Study Sites (1)

Zarqa Governmental Hospital

Zarqa, Please Select, 13133, Jordan

Location

Related Publications (9)

• Tzeng, Y. L., Yang, Y. L., Kuo, P. C., Lin, Y. C., & Chen, S. L. (2017). Pain, anxiety, and fatigue during labor: A prospective, repeated measures study. Journal of Nursing Research, 25(1), 59-67.

  BACKGROUND

• Steimer, T. (2022). The biology of fear-and anxiety-related behaviors. Dialogues in Clinical Neuroscience, 4(3), 231-249. doi: 10.31887/DCNS.2002.4.3/tsteimer

  BACKGROUND

• Salehi, A., Fahami, F., & Beigi, M. (2016). The effect of presence of trained husbands beside their wives during childbirth on women's anxiety. Iranian journal of nursing and midwifery research, 21(6), 611.

  BACKGROUND

• Klabbers, G. A., van Bakel, H. J., van den Heuvel, M., & Vingerhoets, A. J. (2016). Severe fear of childbirth: its features, assesment, prevalence, determinants, consequences and possible treatments. Psihologijske teme, 25(1), 107-127.

  BACKGROUND

• Khamehchian, M., Adib-Hajbaghery, M., HeydariKhayat, N., Rezaei, M., & Sabery, M. (2020). Primiparous women's experiences of normal vaginal delivery in Iran: a qualitative study. BMC pregnancy and childbirth, 20(1), 1-8.

  BACKGROUND

• Hutchison, J., & Mahdy, H. (2019). Stages of labor. [Updated 2022 Feb 2]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK544290/

  BACKGROUND

• Hussein, S., Dahlen, H., Ogunsiji, O., & Schmied, V. (2020). Jordanian women's experiences and constructions of labour and birth in different settings, over time and across generations: a qualitative study. BMC Pregnancy and Childbirth, 20(1). https://doi.org/10.1186/s12884-020-03034-3

  BACKGROUND

• Hijazi, H. H., Alyahya, M. S., Al Abdi, R. M., Alolayyan, M. N., Sindiani, A. M., Raffee, L. A., . . . Al Marzouqi, A. M. (2021). The Impact of Perceived Social Support During Pregnancy on Postpartum Infant-Focused Anxieties: A Prospective Cohort Study of Mothers in Northern Jordan. International Journal of Women's Health, 13, 973.

  BACKGROUND

• Asselmann, E., Kunas, S. L., Wittchen, H.-U., & Martini, J. (2020). Maternal personality, social support, and changes in depressive, anxiety, and stress symptoms during pregnancy and after delivery: A prospective-longitudinal study. PloS One, 15(8), e0237609.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 20, 2026
• Study Start: December 15, 2021
• Primary Completion: March 30, 2022
• Study Completion: May 15, 2022
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 3 month after publication

Locations

JO (1)