Determining the Severity of Physical Symptoms Displayed and Their Level of Perceived Readiness for Discharge After Birth

Post Procedural Discharge Clinical Trial

Official title:

Determining the Severity of Physical Symptoms Displayed by Mothers Receiving Personalized Care and Their Level of Perceived Readiness for Discharge After Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656756
• Other study ID #: Personalized Phy. Symp. Disc.
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2020
• Source: Kutahya Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

H1a: There is a difference between the severity of physical symptoms displayed by puerperal women who received routine and personalized care during the early postpartum period.

H1b: There is a difference between the levels of readiness for discharge among puerperal women who received routine and personalized care during the early postpartum period.

H0a: There is no difference between the severity of physical symptoms displayed by puerperal women who received routine and personalized care during the early postpartum period.

H0b: There is no difference between the levels of readiness for discharge among puerperal women who received routine and personalized care during the early postpartum period.

Description:

This single-blind randomized controlled trial was conducted between the February and December of 2019. The study was carried out at tertiary care hospital in Turkey. The population of this study consisted of the puerperal women who performed vaginal birth at the maternity unit of a hospital.

Considering the possibility that participants of the sample might be lost or abandon the study, 120 mothers who met the criteria of inclusion to experimental (E) (n=60) and control (C) (n=60) groups were included and assigned to both groups using the permuted block randomization method.The investigators randomly allocated the participants either to the intervention group (which received the personalized care), or to control group (which received the routine care). The mothers in the experimental group (60) were administered personalized care while those in the control group (60) were given the routine care.

The pre-test procedure was performed when the mothers' statuses were stabilized one hour after the admittance to the maternity service. The post-test procedure was conducted one hour before the discharge. Routine care was provided to the mothers in both groups. Routine care means the standard care service provided to mothers following the birth. The standard postpartum basic care components were determined based on the guides and protocols of the hospital. There are three core components of postpartum care regarding the routine care service.

The data were collected using the ''Personal Information Form'', ''Postpartum Physical Symptom Severity Scale'' and ''Perceived Readiness for Discharge After Birth Scale-Form for New Mothers (PRDABS-FNM)''.

Statistical analyses were performed using IBM SPSS (Statistical Package for Social Sciences) Statistics 22 software. Descriptive statistics (mean, standard deviation, frequency and percentage values) were used to assess the results. Kolmogorov-Smirnov test was used to review the goodness of fit to normal distribution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To receive personalized care

• To have vaginal birth

• To have singleton birth

• To be within the early postpartum period (the first 24 hours)

• Not have complications childbirth

• Not have chronic diseases or mental disorders

• Older than 18 years

• To voluntary to participate

• To know how to read, write and speak in Turkish

• To stay within this study until the end

• To fully complete questionnaire

• To have a newborn with no complications

• To have a healthy baby

Exclusion Criteria:

• To receive routine care

• To received theoretical training,

• Not have vaginal birth

• Having multiple birth

• Not to be within the early postpartum period (the first 24 hours)

• Having complications childbirth

• Having chronic diseases or mental disorders

• Younger than 18 years

• To refuse to participate

• Not knowing how to read, write and speak Turkish

• To leave early this study

• Not fill the questionnaire

• Having a newborn with complications

• Having a baby in need of medical care

Related Conditions & MeSH terms

• Pain
• Physical Suffering
• Post Procedural Discharge
• Stress, Psychological

Intervention

Behavioral:
• Personalized Care
A clinical and standardized workflow was created for both experimental and control groups. This standardized workflow: consisted of services which included the management of basic medications, routine care regarding the postpartum period, newborn care and health education. After the standardized clinic workflow was formed, a personalized care plan was developed for the experimental group. Each care procedure was shared with the participants in the experimental group. Moreover, all potential alternative care plans were presented to the participants.

Locations

Country	Name	City	State
Turkey	Kutahya Health Science University	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Aysegul Durmaz

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633. — View Citation

Ceylan B, Eser I. Assessment of individualized nursing care in hospitalized patients in a university hospital in Turkey. J Nurs Manag. 2016 Oct;24(7):954-961. doi: 10.1111/jonm.12400. Epub 2016 Jun 14. — View Citation

Chien LY, Tai CJ, Hwang FM, Huang CM. Postpartum physical symptoms and depressive symptomatology at 1 month and 1 year after delivery: a longitudinal questionnaire survey. Int J Nurs Stud. 2009 Sep;46(9):1201-8. doi: 10.1016/j.ijnurstu.2009.02.007. Epub 2 — View Citation

Durmaz A, Komurcu N. Relationship Between Maternal Characteristics and Postpartum Hemorrhage: A Meta-Analysis Study. J Nurs Res. 2018 Oct;26(5):362-372. doi: 10.1097/jnr.0000000000000245. — View Citation

Finlayson K, Crossland N, Bonet M, Downe S. What matters to women in the postnatal period: A meta-synthesis of qualitative studies. PLoS One. 2020 Apr 22;15(4):e0231415. doi: 10.1371/journal.pone.0231415. eCollection 2020. Review. — View Citation

Forster DA, McLachlan HL, Davey MA, Biro MA, Farrell T, Gold L, Flood M, Shafiei T, Waldenström U. Continuity of care by a primary midwife (caseload midwifery) increases women's satisfaction with antenatal, intrapartum and postpartum care: results from th — View Citation

Jansson I, Pilhamar E, Forsberg A. Factors and conditions that have an impact in relation to the successful implementation and maintenance of individual care plans. Worldviews Evid Based Nurs. 2011 Jun;8(2):66-75. doi: 10.1111/j.1741-6787.2010.00195.x. Ep — View Citation

Johansson M, Thies-Lagergren L, Wells MB. Mothers´ experiences in relation to a new Swedish postnatal home-based model of midwifery care-A cross-sectional study. Midwifery. 2019 Nov;78:140-149. doi: 10.1016/j.midw.2019.07.010. Epub 2019 Jul 15. — View Citation

Knier S, Stichler JF, Ferber L, Catterall K. Patients' perceptions of the quality of discharge teaching and readiness for discharge. Rehabil Nurs. 2015 Jan-Feb;40(1):30-9. doi: 10.1002/rnj.164. Epub 2014 Jun 24. — View Citation

McCarter-Spaulding D, Shea S. Effectiveness of Discharge Education on Postpartum Depression. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):168-72. doi: 10.1097/NMC.0000000000000236. — View Citation

Nurhayati N, Songwathana P, Vachprasit R. Surgical patients' experiences of readiness for hospital discharge and perceived quality of discharge teaching in acute care hospitals. J Clin Nurs. 2019 May;28(9-10):1728-1736. doi: 10.1111/jocn.14764. Epub 2019 — View Citation

Poochikian-Sarkissian S, Sidani S, Ferguson-Pare M, Doran D. Examining the relationship between patient-centred care and outcomes. Can J Neurosci Nurs. 2010;32(4):14-21. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre- Test Severity of Physical Symptoms	Postpartum Physical Symptom Severity Scale; this 4-point Likert scale has 18 items aiming to determine the physical postpartum symptoms. The scale is scored as 0 (none), 1 (mild), 2 (moderate) and 3 (severe). The scale assesses the physical symptoms, such as perineum pain, insomnia, constipation, backpain, headache, hemorrhoid, arthralgia, numbness in hands and feet, vaginal discharge and infection, vaginal bleeding, urinary tract infections, dizziness, varicose vein in legs, urinary incontinence, feeling cold abnormally or coldness in hands and feet, and it evaluates the severity of these symptoms. The total scale score varies between 0 and 54. An increase in the score obtained from the scale indicates high severity of physical postpartum symptoms.	1 hour after the admittance to the maternity service
Primary	Pre-Test Readiness for Discharge After Birth	Perceived Readiness for Discharge After Birth Scale-Form for New Mothers (PRDABS-FNM); This is a scale assessing the readiness for discharge by mothers' perceptions. It consists of four subdimensions and 23 items. The first item is answered dichotomously (yes/no). The items between 2 and 23 are calculated through the Likert type points ranging from 0 to 10. The subdimensions consisted of 1. Care skills, 2. Expected support; 3. Strength and ability to cope; 4. Stress control and knowledge of accessing help. The lowest and highest scores are 0 and 220. High scores indicate women's readiness for discharge.	1 hour after the admittance to the maternity service
Secondary	Post-Test Severity of Physical Symptoms	Postpartum Physical Symptom Severity Scale; this 4-point Likert scale has 18 items aiming to determine the physical postpartum symptoms. The scale is scored as 0 (none), 1 (mild), 2 (moderate) and 3 (severe). The scale assesses the physical symptoms, such as perineum pain, insomnia, constipation, backpain, headache, hemorrhoid, arthralgia, numbness in hands and feet, vaginal discharge and infection, vaginal bleeding, urinary tract infections, dizziness, varicose vein in legs, urinary incontinence, feeling cold abnormally or coldness in hands and feet, and it evaluates the severity of these symptoms. The total scale score varies between 0 and 54. An increase in the score obtained from the scale indicates high severity of physical postpartum symptoms.	1 hour before the discharge
Secondary	Post-Test Severity of Physical Symptoms	Perceived Readiness for Discharge After Birth Scale-Form for New Mothers (PRDABS-FNM); This is a scale assessing the readiness for discharge by mothers' perceptions. It consists of four subdimensions and 23 items. The first item is answered dichotomously (yes/no). The items between 2 and 23 are calculated through the Likert type points ranging from 0 to 10. The subdimensions consisted of 1. Care skills, 2. Expected support; 3. Strength and ability to cope; 4. Stress control and knowledge of accessing help. The lowest and highest scores are 0 and 220. High scores indicate women's readiness for discharge.	1 hour before the discharge