Effects of Reflexology on Postpartum Pain, Fatigue, Sleep Quality and Lactation

NCT04924439 | Completed DMC

• 1 other identifier: reflexology and cesarean
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research is to determine the effect of foot reflexology applied to primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep quality and lactation. This research is a randomized controlled trial. The study was conducted in Şanlıurfa, which has the highest fertility rate in Turkey.

Conditions

Breast Feeding; Fatigue; Sleep; Pain, Postoperative

Keywords

fatigue; lactation; pain; postpartum; sleep quality; reflexology

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale (VAS)

  The scale developed by Huskisson (1974) is used for pain assessment in musculoskeletal system and other clinical assessments. VAS is used to convert some values that cannot be measured numerically to numeric. It is a frequently used measurement tool because it is easy and safe to apply. The words "I have no pain" on the left end of the 10 cm long horizontal line and "I have pain" on the right end. The individual is asked to mark the point on this horizontal line that best expresses the severity of pain in his body. The distance from the point marked by the individual to the left end is measured and the pain score is determined. It is evaluated that the severity of the pain increases as the VAS value approaches 10, and decreases as it approaches 0. The lowest 0 and the highest 10 points are taken from the scale.

  Change from Visual Analogue Scale (VAS) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]

• Visual Similarity Scale for Fatigue (YSSF)

  It is in the form of a 10 cm ruler with the most positive statements on one end of the scale and the most negative statements on the other. The most positive expression of the fatigue sub-dimension is 0, the most negative expression is 10, the most negative expression of the energy sub-dimension is 0, and the most positive expression is 10. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate a high severity of fatigue. The calculation method of the scale is determined by adding up all the scores obtained from the scale items. The lowest score for YSSF is 0, and the highest score is 180. The lowest score for the YSSF fatigue sub-dimension is 0, and the highest score is 130. The lowest score is 0 for the energy sub-dimension of YSSF and the highest score is 50. The scale does not have a cut-off point.

  Change from Visual Similarity Scale for Fatigue (YSSF) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]

• Pittsburg Sleep Quality Index (PSQI)

  In order to evaluate the sleep quality in the last month, Buysse et al. (1989) is a quantitative measure of sleep quality as good and bad sleep. Its Turkish adaptation was done by Ağargün et al. (1996), Cronbach's α internal consistency coefficient is 0.80. It consists of a total of 24 questions and 7 sub-components. 18 items and 7 sub-components are included in the scoring. Each item is evaluated as 0-3 points and the sum of 7 sub-components forms the PSQI score. The lowest score of the scale is 0 and the highest score is 21. A total PSQI score of ≤5 indicates good sleep, and \>5 indicates poor sleep.

  Change from Pittsburg Sleep Quality Index (PSQI) scores at first, fourth and eighth week after cesarean. ]

• Bristol Breastfeeding Assessment Tool (BBAT)

  Each item in the scoring of the scale is between 0-2 points. The calculation method is the sum of all scores obtained from the scale items. The lowest score obtained from the scale is 0, and the highest score is 8. The scale does not have a breakpoint. A low score indicates that breastfeeding is ineffective, and a high score indicates that breastfeeding is effective.

  Change from Bristol Breastfeeding Assessment Tool (BBAT) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]

Study Arms (2)

experimental group (foot reflexology group)

EXPERIMENTAL

Primiparas appropriate for the criteria, admitted to the clinic due to CS and accepting to participate in the study were randomly placed into groups. Reflexology was performed in the intervention group mothers, and the questionnaires and scales were self-reportingly filled in by the lead researcher (SC). Different rooms were allocated for the participants in the intervention and control groups not to affect each other. Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks.

Other: foot reflexology

control group

NO INTERVENTION

Primiparas appropriate for the criteria, admitted to the clinic due to CS and accepting to participate in the study were randomly placed into groups. Reflexology was performed in the intervention group mothers, and the questionnaires and scales were self-reportingly filled in by the lead researcher (SC). Different rooms were allocated for the participants in the intervention and control groups not to affect each other.

Interventions

foot reflexology OTHER

Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks. The control group was only watched.

experimental group (foot reflexology group)

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caesarean section,
• Primipary,
• and over and under 35
• Literate,
• and above pregnancy week
• Giving birth singularly,
• Having spinal anesthesia
• No chronic disease or pregnancy complication,
• Have no breast-related health problems
• Have not had an operation related to the breast,
• Women who do not have any health problems in the feet of the mothers in the treatment group

You may not qualify if:

• The baby has died or is not present,
• Multiparous,
• Women with health problems in their feet

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University Health Sciences Enstitutes

Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding; Fatigue; Pain, Postoperative; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Neurologic Manifestations; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• simge zeyneloğlu, proffessor

  GAZİANTEP UNİVERSİTY CLINICAL RESEARCH ETHICS COMMITTE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Small papers with 40 experiments and 40 controls were folded and put into closed, sealed, opaque envelopes, then all the envelopes were put in a bag and mixed. The women were asked to choose one envelope from the bag, and it was determined whether the experimental or control group they were included in before the application. The women in the study did not know which of the experimental and control groups they were included in, and the statistical analysis was planned double-blind, as an independent statistician apart from the researchers did it. Statistical analysis of the research was carried out independently by a statistician.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 14, 2021
• Study Start: January 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)