Labor DeliverySSPNCT07539376
Effect of Social Support During Labor
A study testing Supportive person during labor in people with Labor Delivery and Maternal and Neonatal Outcomes, run by The Hashemite University at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Delivery, Maternal and Neonatal Outcomes
- What is being tested?
- Supportive person during labor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteJordan
- Study dates
- 15 Dec 2021to 15 May 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- High risk pregnancies
- pre term pregnancies
- obstructed labor
- intra uterine fetal death
- still birth
- in vitro fertilization
Show all 10Show fewer
- twins pregnancy
- abnormalities in fetus
- with chronic disease
- psychological problem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Social Support During Labor on Satisfaction, Anxiety and Pain Level at a Jordanian Governmental Hospital
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)
Read more
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.
Read the detailed description
Introduction The labor process occurs in four successive stages. The first stage begins with regular uterine contractions until full dilation of the cervix. The second stage ends with the delivery of the baby, during which the uterine walls contract to push the it out through the cervix. This stage includes "intense engagement, descent, flexion, internal rotation, extension, external rotation, and expulsion" (Hutchison \& Mahdy, 2019, p. 122). The third stage spans from the birth of the baby to the delivery of the placenta, and the fourth (final) stage extends from the delivery of the placenta to two hours postpartum (Hutchison \& Mahdy, 2019).
The amount of pain and the associated psychological stress emphasizes the need for psychosocial and spiritual support for women during childbirth. Gaskin (2010) highlights that spiritual midwives play a key role in helping women cope with the intense challenges of labor. Similarly, several studies have reported that social support in the labor room enhances the delivery process, increases woman's comfort and satisfaction, improves the newborn's Apgar score, decreases the need for analgesia, shortens the duration of labor, and reduces the need for medications used to accelerate delivery (Kabakian-Khasholian et al., 2018; Khamehchian et al., 2020; Lunda, Minnie and Benade, 2018; Gizachew et al., 2021).
Although many research studies have pointed out the benefit of social support during childbirth, there was evidence reporting various factors might influence its positive impact. For example, Al Ahmar and Tarraf (2014) revealed that higher levels of satisfaction with the childbirth experience were significantly associated with factors such as age, multiparity, higher education, high monthly income, unemployment, childbirth preparation, strong personal control and self-efficacy, fulfilled expectations, shorter labor duration, and instrumental delivery. In addition, the World Health Organization (WHO, 2018) recommended that every woman has to be offered the option of having a support person a Unfortunately, in Jordanian government hospitals, family members are not allowed in the labor ward. A qualitative study examined Jordanian women's experiences and perceptions of labor and birth in different settings and found that women who gave birth in government hospitals complained about being alone in the labor room and not being allowed to have any family members stay with them (Hussein et al., 2020). On the other hand, due to a shortage of staff in these hospitals, there is limited opportunity to provide one-to-one nursing care. As a result, laboring women are often left alone, especially during the first stage of labor (Khresheh, 2010).
Previous studies in Jordan have not provided sufficient evidence in this area over the past years. Only one survey conducted by Hijazi et al. (2021) evaluated the association between the perceived social support during pregnancy and anxiety levels among postpartum women, using an anxiety-specific screening instrument in northern Jordan. The study revealed that social support during pregnancy, childbirth, and postpartum period helps reduce anxiety among women in labor wards.
Therefore, this study seeks to investigate the effect of the presence of a social support person with a woman during the first and second stages of labor on her levels of satisfaction, anxiety, and pain at a governmental hospital in Jordan. Furthermore, the study aims to examine the influence of women's sociodemographic factors on the levels of pain, anxiety, and satisfaction during the first and second stages of labor.
Materials and Methods Design A randomized controlled trial (RCT) was utilized in this study. This design was selected as it is considered a powerful approach for testing cause-and-effect relationships due to control, manipulation, and randomization (Polit \& Beck, 2017). Moreover, RTCs contribute to translating research findings into clinical practice, provide strong evidence for medical treatments, and support the evaluation of the effectiveness of clinical interventions.
Setting The study was conducted at al-Basheer Hospital, a governmental hospital in Amman, the capital of Jordan. The hospital was established in 1954 by the late His Majesty King Hussein Bin Talal under the name Al-Ashrafieh Hospital, and was later renamed Al-Basheer Hospital in 1977. This site was chosen because it reflects a typical setting where the presence of family members during labor is generally not permitted. Therefore, women often experience labor alone. However, each shift typically includes two resident physicians and three to four midwives.
Sample A total of 150 pregnant women were conveniently recruited from the designated hospital and randomly assigned into two groups of 75 participants each, forming the interventional and control groups. Researchers used a statistical power of 0.8, a medium effect size of 0.5, and a significance level of 0.05 were used to calculate the sample size. Although the required sample size was initially determined to be 120 participants, a 20% attrition rate was anticipated. Thus, the final sample size was increased to 150 women to ensure sufficient statistical validity.
The inclusion criteria were as follows: woman in the active phase of labor, low-risk pregnancy as determined by obstetrician, term pregnancy, carrying a singleton fetus, aged between 15 and 49 years (reproductive age), and with the ability to read and write (at least at a primary education level).
Ethical considerations Ethical approval was obtained from The Hashemite University Institutional Review Board, IRB (NO3/3/2021/2022). In addition, permissions were gained from Al-Basheer Hospital and the Ministry of Health prior to conducting the study. Approval to use the study instruments was also received from the original author. Before data collection, written informed consent was obtained from all participants, ensuring their voluntary participation and the right to withdraw from the study at any time without any consequences.
Moreover, the study ensured the privacy of all participants and other women present in the labor room. Detailed information about the purpose of the study, as well as the potential risks and benefits of participation, was provided to the participants. Participation was entirely voluntary, with no coercion exerted by the researcher. All collected data kept confidential, and identification numbers were used to link participants' responses to their questionnaires instead of using real names. Furthermore, no invasive procedures were involved in the study.
Data collection instruments Data were collected using five structured questionnaires: a demographic sheet for the women and her support person (if present), an obstetrical data questionnaire, the Satisfaction with Childbirth Experience Questionnaire, an anxiety scale, and a numeric analog scale for pain assessment. Prior to the actual data collection, a pilot study was carried out on a sample of 20 participants to test the instrument's reliability. The Cronbach's alpha values indicated high internal consistency, with 0.92 for the satisfaction questionnaire and 0.83 for the anxiety scale.
The demographic sheet gathered information on each woman's age, income, marital status, religion, occupation, and education level. Regarding the support person, data collected included age, marital status, relationship to the women, and educational level.
The obstetrical data questionnaire gathered detailed information on the health of both the mother and her baby. This included the number of antenatal clinic visits, gestational age of fetus at birth, type of healthcare provider present during delivery, complications during the intrapartum, baby's birth weight, mode of delivery, use of Pethidine, neonatal complications, any interventions performed on the baby, duration of first stage of labor; and baby's Apgar score at 1 and 5 minutes after delivery (Chunuan, 2010).
The Satisfaction with Childbirth Experience Questionnaire (SCEQ) consisted of 20 items was developed to evaluate the laboring women's experience during childbirth. Nineteen items stressed on satisfaction with different aspects of care, including physical and emotional support, medical treatment, pain management, and health education, while one item measured overall satisfaction with the childbirth experience. Each item was worded as a statement requesting a response that ranged from 1 = lowest level of satisfaction to 5 = highest level of satisfaction. The items were summed, resulting in a possible range of scores from 20 to 100. A higher score indicated greater satisfaction. The questionnaire demonstrated high reliability, with a Cronbach's alpha coefficient of 0.92 (Chunuan et al., 2010).
The Anxiety Scale included 19 items that addressed feelings of anxiety during intrapartum. Five of the items are stated in a positive manner; thus, they require reverse scoring (items 1, 2, 4, 6, and 10). Each item in the scale is worded as a statement that requires a rating from 1 = never to 5 = most of the time. The range of possible scores is from 19 to 95. The higher the score, the higher the level of anxiety. The original scale was developed by Boonpongmanee and Sopen Chunuan (2005) and later modified in 2010 by Sopen Chunuan. In this study, we used the modified version. The alpha coefficient was 0.83, which means good reliability for this scale. (Chunuan et al., 2010).
The pain scale was a numeric rating scale consisting of ten levels of pain (0 to 10) marked on a horizontal line. The line was divided into equal sections, numbered from 0 = no pain to 10 = strong pain. Participants rated their labor pain on the analog pain scale by placing an "X" near the number that best represented the level of pain they were experiencing (Chunuan et al., 2010).
All questionnaires were translated into Arabic to make them understandable by the participants, then back-translated into English to ensure their validity. The Arabic version of the questionnaire was reviewed by three experts in the field of midwifery and maternal health to confirm content validity, and the Content Validity Index (CVI) was calculated at 0.97. Further, the Arabic version was modified based on the experts notes, which mainly involved simple language adjustments.
Data collection procedure At the onset of labor, both the laboring woman and her support person were given sufficient information about the labor process. The support person was a female relative chosen by the laboring woman to accompany her throughout labor. The support persons were guided on how to support the laboring women and were careful to fulfill their role. The role of the support person in the labor room included providing a continuous presence, reassurance and praise, comforting touch, and overall continuous labor support from their birth partner until the end of the first stage, and continuing to provide assistance throughout the second stage of labor. Finally, after two hours and at the end of the fourth stage of labor, each woman was interviewed face-to-face by the researcher and completed the questionnaire for both groups.
Data Analysis Statistical analysis of the data was performed using SPSS version 25.0. Both descriptive and inferential statistics consisting of frequencies, percentages, means, standard deviations, and independent t-tests to analyze the data. The significance level was set at (p = < 0.05).
- Conditions
- Labor Delivery, Maternal and Neonatal Outcomes
- Being tested
- Supportive person during labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive person during laborOther
Presence of support female person in labor room during stages of labor
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | group who will get the intervention that is presence of supportive person during labor. Receives: Other: Supportive person during labor |
| control | No intervention | group without the supportive pearson during labor and be given the standard care in labor room. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two days during labor and giving birth process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Dec 2021
- Primary completion30 Mar 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Labor DeliveryStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hashemite University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamila Abuidhail, The Hashemite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539376
- Sponsor's protocol ID
- No.3/3/2021/2022
- Acronym
- SSP
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcomes of the study
Publications
Tzeng YL, Yang YL, Kuo PC, Lin YC, Chen SL. Pain, Anxiety, and Fatigue During Labor: A Prospective, Repeated Measures Study. J Nurs Res. 2017 Feb;25(1):59-67. doi: 10.1097/jnr.0000000000000165.
PubMed 28072678Steimer T. The biology of fear- and anxiety-related behaviors. Dialogues Clin Neurosci. 2002 Sep;4(3):231-49. doi: 10.31887/DCNS.2002.4.3/tsteimer.
PubMed 22033741Salehi A, Fahami F, Beigi M. The effect of presence of trained husbands beside their wives during childbirth on women's anxiety. Iran J Nurs Midwifery Res. 2016 Nov-Dec;21(6):611-615. doi: 10.4103/1735-9066.197672.
PubMed 28194202Klabbers, 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.
Khamehchian M, Adib-Hajbaghery M, HeydariKhayat N, Rezaei M, Sabery M. Primiparous women's experiences of normal vaginal delivery in Iran: a qualitative study. BMC Pregnancy Childbirth. 2020 Apr 29;20(1):259. doi: 10.1186/s12884-020-02954-4.
PubMed 32349704Hutchison, 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/
Hussein SAAA, Dahlen HG, Ogunsiji O, Schmied V. Jordanian women's experiences and constructions of labour and birth in different settings, over time and across generations: a qualitative study. BMC Pregnancy Childbirth. 2020 Jun 10;20(1):357. doi: 10.1186/s12884-020-03034-3.
PubMed 32522158Hijazi HH, Alyahya MS, Al Abdi RM, Alolayyan MN, Sindiani AM, Raffee LA, Baniissa WA, Al Marzouqi AM. The Impact of Perceived Social Support During Pregnancy on Postpartum Infant-Focused Anxieties: A Prospective Cohort Study of Mothers in Northern Jordan. Int J Womens Health. 2021 Oct 21;13:973-989. doi: 10.2147/IJWH.S329487. eCollection 2021.
PubMed 34707417Asselmann E, Kunas SL, Wittchen HU, Martini J. Maternal personality, social support, and changes in depressive, anxiety, and stress symptoms during pregnancy and after delivery: A prospective-longitudinal study. PLoS One. 2020 Aug 24;15(8):e0237609. doi: 10.1371/journal.pone.0237609. eCollection 2020.
PubMed 32833975
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Social Support During Labor on Satisfaction, Anxiety and Pain Level at a Jordanian Governmental Hospital
- ClinicalTrials.gov ID
- NCT07539376
- Acronym / sponsor ID
- SSP / No.3/3/2021/2022
- Conditions
- Labor Delivery, Maternal and Neonatal Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Hashemite UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 20 Apr 2026 (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.
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.
Detailed description
Introduction The labor process occurs in four successive stages. The first stage begins with regular uterine contractions until full dilation of the cervix. The second stage ends with the delivery of the baby, during which the uterine walls contract to push the it out through the cervix. This stage includes "intense engagement, descent, flexion, internal rotation, extension, external rotation, and expulsion" (Hutchison \& Mahdy, 2019, p. 122). The third stage spans from the birth of the baby to the delivery of the placenta, and the fourth (final) stage extends from the delivery of the placenta to two hours postpartum (Hutchison \& Mahdy, 2019).
The amount of pain and the associated psychological stress emphasizes the need for psychosocial and spiritual support for women during childbirth. Gaskin (2010) highlights that spiritual midwives play a key role in helping women cope with the intense challenges of labor. Similarly, several studies have reported that social support in the labor room enhances the delivery process, increases woman's comfort and satisfaction, improves the newborn's Apgar score, decreases the need for analgesia, shortens the duration of labor, and reduces the need for medications used to accelerate delivery (Kabakian-Khasholian et al., 2018; Khamehchian et al., 2020; Lunda, Minnie and Benade, 2018; Gizachew et al., 2021).
Although many research studies have pointed out the benefit of social support during childbirth, there was evidence reporting various factors might influence its positive impact. For example, Al Ahmar and Tarraf (2014) revealed that higher levels of satisfaction with the childbirth experience were significantly associated with factors such as age, multiparity, higher education, high monthly income, unemployment, childbirth preparation, strong personal control and self-efficacy, fulfilled expectations, shorter labor duration, and instrumental delivery. In addition, the World Health Organization (WHO, 2018) recommended that every woman has to be offered the option of having a support person a Unfortunately, in Jordanian government hospitals, family members are not allowed in the labor ward. A qualitative study examined Jordanian women's experiences and perceptions of labor and birth in different settings and found that women who gave birth in government hospitals complained about being alone in the labor room and not being allowed to have any family members stay with them (Hussein et al., 2020). On the other hand, due to a shortage of staff in these hospitals, there is limited opportunity to provide one-to-one nursing care. As a result, laboring women are often left alone, especially during the first stage of labor (Khresheh, 2010).
Previous studies in Jordan have not provided sufficient evidence in this area over the past years. Only one survey conducted by Hijazi et al. (2021) evaluated the association between the perceived social support during pregnancy and anxiety levels among postpartum women, using an anxiety-specific screening instrument in northern Jordan. The study revealed that social support during pregnancy, childbirth, and postpartum period helps reduce anxiety among women in labor wards.
Therefore, this study seeks to investigate the effect of the presence of a social support person with a woman during the first and second stages of labor on her levels of satisfaction, anxiety, and pain at a governmental hospital in Jordan. Furthermore, the study aims to examine the influence of women's sociodemographic factors on the levels of pain, anxiety, and satisfaction during the first and second stages of labor.
Materials and Methods Design A randomized controlled trial (RCT) was utilized in this study. This design was selected as it is considered a powerful approach for testing cause-and-effect relationships due to control, manipulation, and randomization (Polit \& Beck, 2017). Moreover, RTCs contribute to translating research findings into clinical practice, provide strong evidence for medical treatments, and support the evaluation of the effectiveness of clinical interventions.
Setting The study was conducted at al-Basheer Hospital, a governmental hospital in Amman, the capital of Jordan. The hospital was established in 1954 by the late His Majesty King Hussein Bin Talal under the name Al-Ashrafieh Hospital, and was later renamed Al-Basheer Hospital in 1977. This site was chosen because it reflects a typical setting where the presence of family members during labor is generally not permitted. Therefore, women often experience labor alone. However, each shift typically includes two resident physicians and three to four midwives.
Sample A total of 150 pregnant women were conveniently recruited from the designated hospital and randomly assigned into two groups of 75 participants each, forming the interventional and control groups. Researchers used a statistical power of 0.8, a medium effect size of 0.5, and a significance level of 0.05 were used to calculate the sample size. Although the required sample size was initially determined to be 120 participants, a 20% attrition rate was anticipated. Thus, the final sample size was increased to 150 women to ensure sufficient statistical validity.
The inclusion criteria were as follows: woman in the active phase of labor, low-risk pregnancy as determined by obstetrician, term pregnancy, carrying a singleton fetus, aged between 15 and 49 years (reproductive age), and with the ability to read and write (at least at a primary education level).
Ethical considerations Ethical approval was obtained from The Hashemite University Institutional Review Board, IRB (NO3/3/2021/2022). In addition, permissions were gained from Al-Basheer Hospital and the Ministry of Health prior to conducting the study. Approval to use the study instruments was also received from the original author. Before data collection, written informed consent was obtained from all participants, ensuring their voluntary participation and the right to withdraw from the study at any time without any consequences.
Moreover, the study ensured the privacy of all participants and other women present in the labor room. Detailed information about the purpose of the study, as well as the potential risks and benefits of participation, was provided to the participants. Participation was entirely voluntary, with no coercion exerted by the researcher. All collected data kept confidential, and identification numbers were used to link participants' responses to their questionnaires instead of using real names. Furthermore, no invasive procedures were involved in the study.
Data collection instruments Data were collected using five structured questionnaires: a demographic sheet for the women and her support person (if present), an obstetrical data questionnaire, the Satisfaction with Childbirth Experience Questionnaire, an anxiety scale, and a numeric analog scale for pain assessment. Prior to the actual data collection, a pilot study was carried out on a sample of 20 participants to test the instrument's reliability. The Cronbach's alpha values indicated high internal consistency, with 0.92 for the satisfaction questionnaire and 0.83 for the anxiety scale.
The demographic sheet gathered information on each woman's age, income, marital status, religion, occupation, and education level. Regarding the support person, data collected included age, marital status, relationship to the women, and educational level.
The obstetrical data questionnaire gathered detailed information on the health of both the mother and her baby. This included the number of antenatal clinic visits, gestational age of fetus at birth, type of healthcare provider present during delivery, complications during the intrapartum, baby's birth weight, mode of delivery, use of Pethidine, neonatal complications, any interventions performed on the baby, duration of first stage of labor; and baby's Apgar score at 1 and 5 minutes after delivery (Chunuan, 2010).
The Satisfaction with Childbirth Experience Questionnaire (SCEQ) consisted of 20 items was developed to evaluate the laboring women's experience during childbirth. Nineteen items stressed on satisfaction with different aspects of care, including physical and emotional support, medical treatment, pain management, and health education, while one item measured overall satisfaction with the childbirth experience. Each item was worded as a statement requesting a response that ranged from 1 = lowest level of satisfaction to 5 = highest level of satisfaction. The items were summed, resulting in a possible range of scores from 20 to 100. A higher score indicated greater satisfaction. The questionnaire demonstrated high reliability, with a Cronbach's alpha coefficient of 0.92 (Chunuan et al., 2010).
The Anxiety Scale included 19 items that addressed feelings of anxiety during intrapartum. Five of the items are stated in a positive manner; thus, they require reverse scoring (items 1, 2, 4, 6, and 10). Each item in the scale is worded as a statement that requires a rating from 1 = never to 5 = most of the time. The range of possible scores is from 19 to 95. The higher the score, the higher the level of anxiety. The original scale was developed by Boonpongmanee and Sopen Chunuan (2005) and later modified in 2010 by Sopen Chunuan. In this study, we used the modified version. The alpha coefficient was 0.83, which means good reliability for this scale. (Chunuan et al., 2010).
The pain scale was a numeric rating scale consisting of ten levels of pain (0 to 10) marked on a horizontal line. The line was divided into equal sections, numbered from 0 = no pain to 10 = strong pain. Participants rated their labor pain on the analog pain scale by placing an "X" near the number that best represented the level of pain they were experiencing (Chunuan et al., 2010).
All questionnaires were translated into Arabic to make them understandable by the participants, then back-translated into English to ensure their validity. The Arabic version of the questionnaire was reviewed by three experts in the field of midwifery and maternal health to confirm content validity, and the Content Validity Index (CVI) was calculated at 0.97. Further, the Arabic version was modified based on the experts notes, which mainly involved simple language adjustments.
Data collection procedure At the onset of labor, both the laboring woman and her support person were given sufficient information about the labor process. The support person was a female relative chosen by the laboring woman to accompany her throughout labor. The support persons were guided on how to support the laboring women and were careful to fulfill their role. The role of the support person in the labor room included providing a continuous presence, reassurance and praise, comforting touch, and overall continuous labor support from their birth partner until the end of the first stage, and continuing to provide assistance throughout the second stage of labor. Finally, after two hours and at the end of the fourth stage of labor, each woman was interviewed face-to-face by the researcher and completed the questionnaire for both groups.
Data Analysis Statistical analysis of the data was performed using SPSS version 25.0. Both descriptive and inferential statistics consisting of frequencies, percentages, means, standard deviations, and independent t-tests to analyze the data. The significance level was set at (p = < 0.05).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Supportive person during laborgroup who will get the intervention that is presence of supportive person during labor. |
| control | No intervention | –group without the supportive pearson during labor and be given the standard care in labor room. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- High risk pregnancies
- pre term pregnancies
- obstructed labor
- intra uterine fetal death
- still birth
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 |
|---|---|---|
| Supportive person during laborPresence of support female person in labor room during stages of labor | Other | intervention |
Primary outcome
satisfaction level
Time frame: two days during labor and giving birth process
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.
anxiety level and pain intensity
Time frame: Two days during labor and giving birth process
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.
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 20 Apr 2026.
- Background: PubMed 28072678Tzeng YL, Yang YL, Kuo PC, Lin YC, Chen SL. Pain, Anxiety, and Fatigue During Labor: A Prospective, Repeated Measures Study. J Nurs Res. 2017 Feb;25(1):59-67. doi: 10.1097/jnr.0000000000000165.
- Background: PubMed 22033741Steimer T. The biology of fear- and anxiety-related behaviors. Dialogues Clin Neurosci. 2002 Sep;4(3):231-49. doi: 10.31887/DCNS.2002.4.3/tsteimer.
- Background: PubMed 28194202Salehi A, Fahami F, Beigi M. The effect of presence of trained husbands beside their wives during childbirth on women's anxiety. Iran J Nurs Midwifery Res. 2016 Nov-Dec;21(6):611-615. doi: 10.4103/1735-9066.197672.
- BackgroundKlabbers, 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: PubMed 32349704Khamehchian M, Adib-Hajbaghery M, HeydariKhayat N, Rezaei M, Sabery M. Primiparous women's experiences of normal vaginal delivery in Iran: a qualitative study. BMC Pregnancy Childbirth. 2020 Apr 29;20(1):259. doi: 10.1186/s12884-020-02954-4.
- BackgroundHutchison, 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: PubMed 32522158Hussein SAAA, Dahlen HG, Ogunsiji O, Schmied V. Jordanian women's experiences and constructions of labour and birth in different settings, over time and across generations: a qualitative study. BMC Pregnancy Childbirth. 2020 Jun 10;20(1):357. doi: 10.1186/s12884-020-03034-3.
- Background: PubMed 34707417Hijazi HH, Alyahya MS, Al Abdi RM, Alolayyan MN, Sindiani AM, Raffee LA, Baniissa WA, Al Marzouqi AM. The Impact of Perceived Social Support During Pregnancy on Postpartum Infant-Focused Anxieties: A Prospective Cohort Study of Mothers in Northern Jordan. Int J Womens Health. 2021 Oct 21;13:973-989. doi: 10.2147/IJWH.S329487. eCollection 2021.
- Background: PubMed 32833975Asselmann E, Kunas SL, Wittchen HU, Martini J. Maternal personality, social support, and changes in depressive, anxiety, and stress symptoms during pregnancy and after delivery: A prospective-longitudinal study. PLoS One. 2020 Aug 24;15(8):e0237609. doi: 10.1371/journal.pone.0237609. eCollection 2020.
- Individual participant dataSharing planned: Yes. Outcomes of the study
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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 Supportive person during labor in people with Labor Delivery and Maternal and Neonatal Outcomes, run by The Hashemite University at 1 site in Jordan.
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 5 inclusion and 10 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 20 Apr 2026. 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 Jordan. 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?
satisfaction level (time frame: two days during labor and giving birth process). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07539376, which also lists 9 linked publications.
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 20 Apr 2026.